ACS Surgery News

PHOENIX – When the entire colon cannot be examined during a colonoscopy, physicians should persevere in obtaining a full colonic evaluation because a sizable share of these patients will have an advanced polyp or cancer, a new study shows.

In the study, which used a prospective institutional database, about 1 in every 8 patients having an incomplete initial colonoscopy were subsequently found to have a clinically significant lesion after undergoing some other type of completion exam, lead investigator Dr. Timothy J. Ridolfi reported at the annual meeting of the American Society of Colon and Rectal Surgeons.

Patients with a personal history of polyps or cancer accounted for two-thirds of all patients who were found to have lesions on completion studies.

"Complete colonic evaluation in patients with an incomplete colonoscopy is important, and repeat colonoscopy is the most efficient way of achieving that," he commented. "Those with a personal history of polyps or cancer have the highest likelihood of a positive finding on repeat colonoscopy."

Session attendee Dr. Joshua Bleier, of the Hospital of the University of Pennsylvania, Philadelphia, asked, "Since you have this prospective database, was any chart review done to follow up on the patients who didn’t have completion evaluations?"

The investigators have not yet assessed outcomes among patients who were offered a completion study but skipped it, according to Dr. Ridolfi, who is a colorectal surgery fellow at the Cleveland Clinic. He noted that some patients may have had such studies done at outside institutions.

Commenting on the research in an interview, comoderator Dr. H. David Vargas, of the Ochsner Medical Center in New Orleans, said that although the study’s findings are not surprising, they are a good reminder to physicians of the need to follow through in cases where a colonoscopy cannot be completed.

Examining the entire colon "is really incumbent upon us. The onus is on us to complete it," he said. The study "confirms why we need to be thorough, if you will."

The investigators analyzed data from a prospective database that captured information on 25,645 colonoscopies performed by colorectal surgeons at the Cleveland Clinic between 1982 and 2009.

A total of 242 patients were identified as having an incomplete initial colonoscopy. The group had a mean age of 59 years, and 69% were women.

The leading reasons for an incomplete procedure were presence of stool, pain, and tortuosity, with the reason varying according to the anatomic extent of the procedure. Fully 71% of procedures were terminated at the splenic flexure or more distally, he reported.

Overall, 90% of the patients were offered some type of completion study, and 82% of this group complied and underwent the study.

The completion study was most commonly a barium enema (41%) or repeat colonoscopy (40%), and less commonly CT colonography (9%), colonoscopy under general anesthesia (5%), or indicated resection with intraoperative or perioperative colonoscopy (5%).

Some 12% of the patients undergoing a barium enema or CT colonography were found to have new abnormalities, according to Dr. Ridolfi.

In addition, 24% of the patients undergoing repeat colonoscopy were found to have polyps. Of the 32 polyps identified (21 located beyond the extent of the initial incomplete colonoscopy), 9 were advanced adenomas.

And 38% of the patients undergoing indicated resection were found to have some additional lesions on their intraoperative or perioperative colonoscopy.

Patients whose indication for the initial colonoscopy was a personal history of polyps or cancer were more likely than those with other indications – a family history, symptoms, or screening – to have lesions on their completion study. In fact, these patients made up 67% of all patients with positive findings.

Ultimately, 12% of the patients undergoing completion studies were determined to have clinically significant lesions that led to polypectomy or partial colectomy.

Dr. Ridolfi disclosed no relevant conflicts of interest.

PHOENIX – When the entire colon cannot be examined during a colonoscopy, physicians should persevere in obtaining a full colonic evaluation because a sizable share of these patients will have an advanced polyp or cancer, a new study shows.

In the study, which used a prospective institutional database, about 1 in every 8 patients having an incomplete initial colonoscopy were subsequently found to have a clinically significant lesion after undergoing some other type of completion exam, lead investigator Dr. Timothy J. Ridolfi reported at the annual meeting of the American Society of Colon and Rectal Surgeons.

Patients with a personal history of polyps or cancer accounted for two-thirds of all patients who were found to have lesions on completion studies.

"Complete colonic evaluation in patients with an incomplete colonoscopy is important, and repeat colonoscopy is the most efficient way of achieving that," he commented. "Those with a personal history of polyps or cancer have the highest likelihood of a positive finding on repeat colonoscopy."

Session attendee Dr. Joshua Bleier, of the Hospital of the University of Pennsylvania, Philadelphia, asked, "Since you have this prospective database, was any chart review done to follow up on the patients who didn’t have completion evaluations?"

The investigators have not yet assessed outcomes among patients who were offered a completion study but skipped it, according to Dr. Ridolfi, who is a colorectal surgery fellow at the Cleveland Clinic. He noted that some patients may have had such studies done at outside institutions.

Commenting on the research in an interview, comoderator Dr. H. David Vargas, of the Ochsner Medical Center in New Orleans, said that although the study’s findings are not surprising, they are a good reminder to physicians of the need to follow through in cases where a colonoscopy cannot be completed.

Examining the entire colon "is really incumbent upon us. The onus is on us to complete it," he said. The study "confirms why we need to be thorough, if you will."

The investigators analyzed data from a prospective database that captured information on 25,645 colonoscopies performed by colorectal surgeons at the Cleveland Clinic between 1982 and 2009.

A total of 242 patients were identified as having an incomplete initial colonoscopy. The group had a mean age of 59 years, and 69% were women.

The leading reasons for an incomplete procedure were presence of stool, pain, and tortuosity, with the reason varying according to the anatomic extent of the procedure. Fully 71% of procedures were terminated at the splenic flexure or more distally, he reported.

Overall, 90% of the patients were offered some type of completion study, and 82% of this group complied and underwent the study.

The completion study was most commonly a barium enema (41%) or repeat colonoscopy (40%), and less commonly CT colonography (9%), colonoscopy under general anesthesia (5%), or indicated resection with intraoperative or perioperative colonoscopy (5%).

Some 12% of the patients undergoing a barium enema or CT colonography were found to have new abnormalities, according to Dr. Ridolfi.

In addition, 24% of the patients undergoing repeat colonoscopy were found to have polyps. Of the 32 polyps identified (21 located beyond the extent of the initial incomplete colonoscopy), 9 were advanced adenomas.

And 38% of the patients undergoing indicated resection were found to have some additional lesions on their intraoperative or perioperative colonoscopy.

Patients whose indication for the initial colonoscopy was a personal history of polyps or cancer were more likely than those with other indications – a family history, symptoms, or screening – to have lesions on their completion study. In fact, these patients made up 67% of all patients with positive findings.

Ultimately, 12% of the patients undergoing completion studies were determined to have clinically significant lesions that led to polypectomy or partial colectomy.

Dr. Ridolfi disclosed no relevant conflicts of interest.

PHOENIX – When the entire colon cannot be examined during a colonoscopy, physicians should persevere in obtaining a full colonic evaluation because a sizable share of these patients will have an advanced polyp or cancer, a new study shows.

In the study, which used a prospective institutional database, about 1 in every 8 patients having an incomplete initial colonoscopy were subsequently found to have a clinically significant lesion after undergoing some other type of completion exam, lead investigator Dr. Timothy J. Ridolfi reported at the annual meeting of the American Society of Colon and Rectal Surgeons.

Patients with a personal history of polyps or cancer accounted for two-thirds of all patients who were found to have lesions on completion studies.

"Complete colonic evaluation in patients with an incomplete colonoscopy is important, and repeat colonoscopy is the most efficient way of achieving that," he commented. "Those with a personal history of polyps or cancer have the highest likelihood of a positive finding on repeat colonoscopy."

Session attendee Dr. Joshua Bleier, of the Hospital of the University of Pennsylvania, Philadelphia, asked, "Since you have this prospective database, was any chart review done to follow up on the patients who didn’t have completion evaluations?"

The investigators have not yet assessed outcomes among patients who were offered a completion study but skipped it, according to Dr. Ridolfi, who is a colorectal surgery fellow at the Cleveland Clinic. He noted that some patients may have had such studies done at outside institutions.

Commenting on the research in an interview, comoderator Dr. H. David Vargas, of the Ochsner Medical Center in New Orleans, said that although the study’s findings are not surprising, they are a good reminder to physicians of the need to follow through in cases where a colonoscopy cannot be completed.

Examining the entire colon "is really incumbent upon us. The onus is on us to complete it," he said. The study "confirms why we need to be thorough, if you will."

The investigators analyzed data from a prospective database that captured information on 25,645 colonoscopies performed by colorectal surgeons at the Cleveland Clinic between 1982 and 2009.

A total of 242 patients were identified as having an incomplete initial colonoscopy. The group had a mean age of 59 years, and 69% were women.

The leading reasons for an incomplete procedure were presence of stool, pain, and tortuosity, with the reason varying according to the anatomic extent of the procedure. Fully 71% of procedures were terminated at the splenic flexure or more distally, he reported.

Overall, 90% of the patients were offered some type of completion study, and 82% of this group complied and underwent the study.

The completion study was most commonly a barium enema (41%) or repeat colonoscopy (40%), and less commonly CT colonography (9%), colonoscopy under general anesthesia (5%), or indicated resection with intraoperative or perioperative colonoscopy (5%).

Some 12% of the patients undergoing a barium enema or CT colonography were found to have new abnormalities, according to Dr. Ridolfi.

In addition, 24% of the patients undergoing repeat colonoscopy were found to have polyps. Of the 32 polyps identified (21 located beyond the extent of the initial incomplete colonoscopy), 9 were advanced adenomas.

And 38% of the patients undergoing indicated resection were found to have some additional lesions on their intraoperative or perioperative colonoscopy.

Patients whose indication for the initial colonoscopy was a personal history of polyps or cancer were more likely than those with other indications – a family history, symptoms, or screening – to have lesions on their completion study. In fact, these patients made up 67% of all patients with positive findings.

Ultimately, 12% of the patients undergoing completion studies were determined to have clinically significant lesions that led to polypectomy or partial colectomy.

Dr. Ridolfi disclosed no relevant conflicts of interest.

ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.

Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.

A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.

Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.

The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.

The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.

"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.

This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.

Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.

The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.

Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.

The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.

Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.

"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.

Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.

Dr. Phatak reported having no disclosures.

ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.

Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.

A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.

Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.

The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.

The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.

"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.

This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.

Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.

The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.

Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.

The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.

Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.

"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.

Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.

Dr. Phatak reported having no disclosures.

ORLANDO – Older age and nighttime surgery were associated with an increased risk of complications in patients undergoing laparoscopic cholecystectomy at a high-volume safety net hospital, according to a retrospective study of cases.

Of 576 operations performed in consecutive patients for whom relevant data were available, 35% were performed at night, and although about 60% of procedures overall were nonelective, more than 90% of those performed at night were nonelective, meaning that most patients were admitted directly from the emergency department, Dr. Uma R. Phatak reported at the annual Digestive Disease Week.

A total of 35 complications occurred in 22 patients, including 18 undergoing nonelective surgery and 4 undergoing elective surgery.

Multivariate analysis demonstrated that age and nighttime surgery were significant predictors of complications, said Dr. Phatak of the University of Texas Health Science Center, Houston.

The probability of a complication increased with age for both the patients who underwent daytime surgery and those who underwent nighttime surgery, but the increase was greater in the nighttime surgery group, she said.

The predicted probability of a complication increased threefold for older patients who underwent surgery at night, according to an analysis by 10-year age intervals.

"At the upper end of the age spectrum, the predicted probability of a complication with surgery at night is about 30%, compared to about 10% in the daytime group," Dr. Phatak said.

This analysis did not adjust for disease severity, but a multivariate model that included the elective surgery patients showed that even in this group, an increased risk of a complication was associated with nighttime surgery and increasing age, she noted.

Patients included in the study underwent surgery during an 8-month period from October 2010 to May 2011 at a hospital with a large Hispanic population at high risk for gallstones where laparoscopic cholecystectomy is commonly performed at night. Most (84%) were women, and most (84%) were Hispanic.

The most common diagnoses were acute cholecystitis in the nighttime group and chronic cholecystitis in the daytime group.

Those who underwent nighttime surgery had a lower median age and a longer median length of stay, although it was unclear whether the length of stay was increased due to a delay in getting to the operating room.

The study is limited by its single-center retrospective design, which limits the generalizability. It also was underpowered to detect significant differences in complications other than surgical site infections, Dr. Phatak noted.

Nonetheless, the study demonstrates an increased risk of complications with nighttime surgery, suggesting that the benefits of early laparoscopic cholecystectomy for acute cholecystitis must be balanced against the risk of nighttime surgery, Dr. Phatak said.

"At our institution, new ambulatory operating rooms will be opening soon, decreasing the burden on the main operating room. This will allow for nonemergent cases to be booked during the daytime without imposing delays in the elective schedule," she said.

Providing increased space for elective operations, identifying high-risk patients, and prioritizing surgeries during the day for those patients may decrease the complication rate and improve outcomes, she concluded.

Dr. Phatak reported having no disclosures.

ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.

Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.

"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.

Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.

To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.

The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.

But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.

In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).

Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.

The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.

*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.

ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.

Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.

"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.

Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.

To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.

The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.

But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.

In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).

Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.

The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.

*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.

ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.

Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.

"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.

Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.

To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.

The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.

But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.

In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).

Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.

The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.

*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.

ORLANDO – Combining surgical resection of primary carcinoid and neuroendocrine tumors with cytoreductive surgery of liver metastases is safe in select patients and can produce outcomes similar to those seen with surgery and adjuvant therapy, said investigators at the annual Digestive Disease Week.

Among 47 patients with carcinoid and neuroendocrine tumors (CNET), 22 of whom underwent simultaneous resection of primary tumors and surgical reduction of metastatic tumor burden with partial or near-total surgical cytoreduction (CR), and 25 of whom had resection of the primary with additional therapies, the 5-year survival rate was 82%, reported Dr. Nicholas N. Nissen of the Cedars-Sinai Medical Center in Los Angeles.

In addition, no patients who had near-total CR required a repeat hepatic intervention within 1 year of surgery, compared with 18 of 25 patients (72%) who had surgery followed by additional hepatic therapy, Dr. Nissen said.

"While most patients progress over time, overall survival is excellent, and we admit very freely that this reflects the growing and evolving multimodal therapies that are available to these patients," Dr. Nissen said.

"We would propose that simultaneous removal of the primary tumor and liver metastases may in fact be primarily beneficial as it consolidates procedures and allows some patients to delay or perhaps even avoid other locoregional hepatic therapies," he added.

The authors took a retrospective look at records of 51 patients, 47 of whom were available for the overall survival analysis. The patients all underwent resection of hepatic masses simultaneously with surgery to remove either small bowel carcinoid (32 patients) or pancreatic neuroendocrine tumor (15 patients). In all, 27 patients had partial surgical cytoreduction of metastases, and 22 had planned near-total surgical CR.

Of the 19 patients with carcinoid syndrome, all had what Dr. Nissen described as "dramatic improvement," and 11 had complete resolution of symptoms following surgery.

There were no deaths within 30 days of surgery. There were eight complications greater than Clavien grade 2, including two instances of bile leak requiring endoscopic retrograde cholangiopancreatography, and four cases requiring repeat laparotomy.

Overall survival for 47 patients with at least 5 years of data was 95% at 1 year, and 82% at years 3 and 5 of follow-up. Overall 5-year survival among those patients who had near-total CR was 88%, compared with 72% of those who had subtotal CR, but the difference was not statistically significant.

The respective progression-free survival rates were 77%, 37%, and 28%. Broken down by treatment type, 5-year PFS was 40% among patients who had near total CR, compared with 22% for those who had subtotal cytoreduction, but this difference was also not significant.

However, the seven patients who had no additional hepatic therapy had a more-than-threefold risk for progression, compared with either near total CR (hazard ratio [HR], 3.10; P = .044) or partial CR with additional liver treatment (HR, 3.37; P =.029).

No demographic or disease-related variables appeared to predict survival, but progression-free survival was significantly associated with poor differentiation (P = .022) and with large tumors (P = .044).

Dr. Carlos Corvera, a gastrointestinal surgeon at the University of California at San Francisco, who was not involved in the study, commented that the worse progression-free survival seen in the seven patients who did not receive adjuvant hepatic therapies suggested a benefit for additional cytoreduction, regardless of whether the patients are having symptoms.

"What do you tell your medical oncology colleagues who argue that disease-specific survival is really the most important thing, and that we end up predisposing these patients to possible [surgical] complications in situations where there’s really no significant survival benefit shown in asymptomatic patients?" he asked

Dr. Nissen replied that with the availability of new targeted systemic and locoregional therapies, in the near future the question may no longer when to operate and with what additional therapies, but "whether to operate."

The study sponsor was not disclosed. Dr. Nissen and Dr. Corvera reported having no relevant financial disclosures.

ORLANDO – Combining surgical resection of primary carcinoid and neuroendocrine tumors with cytoreductive surgery of liver metastases is safe in select patients and can produce outcomes similar to those seen with surgery and adjuvant therapy, said investigators at the annual Digestive Disease Week.

Among 47 patients with carcinoid and neuroendocrine tumors (CNET), 22 of whom underwent simultaneous resection of primary tumors and surgical reduction of metastatic tumor burden with partial or near-total surgical cytoreduction (CR), and 25 of whom had resection of the primary with additional therapies, the 5-year survival rate was 82%, reported Dr. Nicholas N. Nissen of the Cedars-Sinai Medical Center in Los Angeles.

In addition, no patients who had near-total CR required a repeat hepatic intervention within 1 year of surgery, compared with 18 of 25 patients (72%) who had surgery followed by additional hepatic therapy, Dr. Nissen said.

"While most patients progress over time, overall survival is excellent, and we admit very freely that this reflects the growing and evolving multimodal therapies that are available to these patients," Dr. Nissen said.

"We would propose that simultaneous removal of the primary tumor and liver metastases may in fact be primarily beneficial as it consolidates procedures and allows some patients to delay or perhaps even avoid other locoregional hepatic therapies," he added.

The authors took a retrospective look at records of 51 patients, 47 of whom were available for the overall survival analysis. The patients all underwent resection of hepatic masses simultaneously with surgery to remove either small bowel carcinoid (32 patients) or pancreatic neuroendocrine tumor (15 patients). In all, 27 patients had partial surgical cytoreduction of metastases, and 22 had planned near-total surgical CR.

Of the 19 patients with carcinoid syndrome, all had what Dr. Nissen described as "dramatic improvement," and 11 had complete resolution of symptoms following surgery.

There were no deaths within 30 days of surgery. There were eight complications greater than Clavien grade 2, including two instances of bile leak requiring endoscopic retrograde cholangiopancreatography, and four cases requiring repeat laparotomy.

Overall survival for 47 patients with at least 5 years of data was 95% at 1 year, and 82% at years 3 and 5 of follow-up. Overall 5-year survival among those patients who had near-total CR was 88%, compared with 72% of those who had subtotal CR, but the difference was not statistically significant.

The respective progression-free survival rates were 77%, 37%, and 28%. Broken down by treatment type, 5-year PFS was 40% among patients who had near total CR, compared with 22% for those who had subtotal cytoreduction, but this difference was also not significant.

However, the seven patients who had no additional hepatic therapy had a more-than-threefold risk for progression, compared with either near total CR (hazard ratio [HR], 3.10; P = .044) or partial CR with additional liver treatment (HR, 3.37; P =.029).

No demographic or disease-related variables appeared to predict survival, but progression-free survival was significantly associated with poor differentiation (P = .022) and with large tumors (P = .044).

Dr. Carlos Corvera, a gastrointestinal surgeon at the University of California at San Francisco, who was not involved in the study, commented that the worse progression-free survival seen in the seven patients who did not receive adjuvant hepatic therapies suggested a benefit for additional cytoreduction, regardless of whether the patients are having symptoms.

"What do you tell your medical oncology colleagues who argue that disease-specific survival is really the most important thing, and that we end up predisposing these patients to possible [surgical] complications in situations where there’s really no significant survival benefit shown in asymptomatic patients?" he asked

Dr. Nissen replied that with the availability of new targeted systemic and locoregional therapies, in the near future the question may no longer when to operate and with what additional therapies, but "whether to operate."

The study sponsor was not disclosed. Dr. Nissen and Dr. Corvera reported having no relevant financial disclosures.

ORLANDO – Combining surgical resection of primary carcinoid and neuroendocrine tumors with cytoreductive surgery of liver metastases is safe in select patients and can produce outcomes similar to those seen with surgery and adjuvant therapy, said investigators at the annual Digestive Disease Week.

Among 47 patients with carcinoid and neuroendocrine tumors (CNET), 22 of whom underwent simultaneous resection of primary tumors and surgical reduction of metastatic tumor burden with partial or near-total surgical cytoreduction (CR), and 25 of whom had resection of the primary with additional therapies, the 5-year survival rate was 82%, reported Dr. Nicholas N. Nissen of the Cedars-Sinai Medical Center in Los Angeles.

In addition, no patients who had near-total CR required a repeat hepatic intervention within 1 year of surgery, compared with 18 of 25 patients (72%) who had surgery followed by additional hepatic therapy, Dr. Nissen said.

"While most patients progress over time, overall survival is excellent, and we admit very freely that this reflects the growing and evolving multimodal therapies that are available to these patients," Dr. Nissen said.

"We would propose that simultaneous removal of the primary tumor and liver metastases may in fact be primarily beneficial as it consolidates procedures and allows some patients to delay or perhaps even avoid other locoregional hepatic therapies," he added.

The authors took a retrospective look at records of 51 patients, 47 of whom were available for the overall survival analysis. The patients all underwent resection of hepatic masses simultaneously with surgery to remove either small bowel carcinoid (32 patients) or pancreatic neuroendocrine tumor (15 patients). In all, 27 patients had partial surgical cytoreduction of metastases, and 22 had planned near-total surgical CR.

Of the 19 patients with carcinoid syndrome, all had what Dr. Nissen described as "dramatic improvement," and 11 had complete resolution of symptoms following surgery.

There were no deaths within 30 days of surgery. There were eight complications greater than Clavien grade 2, including two instances of bile leak requiring endoscopic retrograde cholangiopancreatography, and four cases requiring repeat laparotomy.

Overall survival for 47 patients with at least 5 years of data was 95% at 1 year, and 82% at years 3 and 5 of follow-up. Overall 5-year survival among those patients who had near-total CR was 88%, compared with 72% of those who had subtotal CR, but the difference was not statistically significant.

The respective progression-free survival rates were 77%, 37%, and 28%. Broken down by treatment type, 5-year PFS was 40% among patients who had near total CR, compared with 22% for those who had subtotal cytoreduction, but this difference was also not significant.

However, the seven patients who had no additional hepatic therapy had a more-than-threefold risk for progression, compared with either near total CR (hazard ratio [HR], 3.10; P = .044) or partial CR with additional liver treatment (HR, 3.37; P =.029).

No demographic or disease-related variables appeared to predict survival, but progression-free survival was significantly associated with poor differentiation (P = .022) and with large tumors (P = .044).

Dr. Carlos Corvera, a gastrointestinal surgeon at the University of California at San Francisco, who was not involved in the study, commented that the worse progression-free survival seen in the seven patients who did not receive adjuvant hepatic therapies suggested a benefit for additional cytoreduction, regardless of whether the patients are having symptoms.

"What do you tell your medical oncology colleagues who argue that disease-specific survival is really the most important thing, and that we end up predisposing these patients to possible [surgical] complications in situations where there’s really no significant survival benefit shown in asymptomatic patients?" he asked

Dr. Nissen replied that with the availability of new targeted systemic and locoregional therapies, in the near future the question may no longer when to operate and with what additional therapies, but "whether to operate."

The study sponsor was not disclosed. Dr. Nissen and Dr. Corvera reported having no relevant financial disclosures.

ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.

In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.

Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.

"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.

The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.

They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.

They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.

At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.

Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.

At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m², compared with a slight loss of –0.2 kg/m² among patients on placebo (P = .03).

More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.

The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.

The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.

ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.

In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.

Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.

"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.

The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.

They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.

They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.

At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.

Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.

At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m², compared with a slight loss of –0.2 kg/m² among patients on placebo (P = .03).

More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.

The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.

The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.

ORLANDO – The tricyclic antidepressant nortriptyline is often prescribed for treatment of nausea, vomiting, and abdominal pain from gastroparesis, but results from a randomized clinical trial suggest that it doesn’t really work, investigators said at the annual Digestive Disease Week.

In a double-masked trial, 15 weeks of treatment with nortriptyline was no better than placebo for management of overall symptoms of idiopathic gastroparesis, reported Dr. Henry P. Parkman from Temple University in Philadelphia.

Although patients started on a 10-mg dose of nortriptyline had early improvement in nausea, this benefit disappeared as the dosage increased. In addition, 19 of the 65 patients assigned to the tricyclic antidepressant (TCA) opted to discontinue treatment early, primarily because of side effects, Dr. Parkman reported.

"Further studies will be needed to determine the role for TCAs and other neuromodulators in patients with idiopathic and also other etiologies of gastroparesis, and also to look at specific symptoms’ improvement associated with TCAs in gastroparesis," he said.

The investigators observed that the practice of treating idiopathic gastroparesis with TCAs is not well supported by clinical evidence, and took it on themselves to see whether they could gather sufficient evidence for or against the efficacy of these agents for this indication.

They chose nortriptyline because of its relatively low anticholinergic side effects, and used a dose-escalating scheme similar to that used in clinical practice.

They enrolled 130 patients into a placebo-controlled, parallel-group trial. Patients randomized to nortriptyline received it at a starting dose of 10 mg daily, which was escalated every 3 weeks to 25, 50, and finally 75 mg.

At the end of the 15 weeks, there were no significant differences between the groups in the primary endpoint, overall symptomatic improvement as measured by change in the 45-point, 9-symptom Gastroparesis Cardinal Symptom Index (GCSI). In all, 15 patients who received the TCA had at least a 50% decline from baseline GCSI score over two consecutive 3-week visits, compared with 14 patients on placebo.

Patients on nortriptyline did have a significant decline in both nausea (P = .04) and abdominal pain (P = .004) at the first visit, but this difference disappeared on subsequent visits.

At the end of the study, patients on the TCA also reported a greater improvement in appetite (P = .03), and showed a nonsignificant trend toward ability to finish a meal (P = .08). Patients on nortriptyline also had a slight gain in body mass index of 0.5 kg/m², compared with a slight loss of –0.2 kg/m² among patients on placebo (P = .03).

More than three times as many patients on nortriptyline stopped treatment early (19 vs. 6, P = .007), primarily because of side effects.

The investigators concluded that the role of TCAs and other neuromodulators for the treatment of idiopathic gastroparesis and other forms of gastrointestinal paralysis needs further exploration.

The study was funded by the National Institutes of Health. Dr. Parkman reported serving on advisory committees and review panels for Tranzyme, and consulting for Evoke, SmartPill, and other companies.

A smartphone application that provides step-by-step instructions for precolonoscopy bowel preparation appears to improve users’ bowel preparation quality, according to early findings from an ongoing study.

The Boston Bowel Preparation Scale score in 16 patients who used the doctor-designed Arizona Digestive Health App was 8.19, which was significantly better than the scores in 162 smartphone users who did not use the app (6.92) and 164 patients without smartphones (6.76). The difference in scores between the smartphone users who didn’t use the app and those without a smartphone was not statistically significant. The findings are being reported during the annual Digestive Disease Week in Orlando.

In an initial phase of the study, the 362 non–app users who underwent screening colonoscopy were simply asked whether they owned a smartphone and about their likelihood of using an app. Bowel preparation quality in those patients was evaluated by a blinded endoscopist, Dr. Nilay H. Kavathia reported during a press conference prior to the meeting

In a second phase, patients were instructed on how to download the app, which includes timed alerts with step-by-step instructions regarding dietary restrictions and use of the prep, as well as photos and tips to ensure patients’ understanding of the process, said Dr. Kavathia of the Carl T. Hayden Veterans Affairs Medical Center in Phoenix.

The information was the same as that provided in written form to those not using the app, he noted.

Bowel preparation quality in these patients was also assessed by a blinded endoscopist.

Though early, the findings are encouraging, given that the success of colonoscopy is largely based on the quality of bowel preparation achieved, Dr. Kavathia said during the press briefing.

"Basically, good colon prep is difficult to do. Inadequate preparation can result in cancellation or a compromised exam ... We believe this app provides an important step in improving patient satisfaction and harnessing technology for better health care outcomes," he added.

Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., agreed, calling the app "ingenious."

"There are a lot of barriers to success of colorectal cancer screening, and one of the main ones is ensuring that the preparation is adequate ... and everyone knows that the worst part of colonoscopy is taking the prep. Anything you can do to encourage patients to complete the prep, and perhaps enjoy doing it a little more than they generally do with the use of an app, I think that’s an ingenious approach that will improve the quality of colorectal cancer screening," he said.

The Arizona Digestive Health App is available for free for both Apple iPhone and Android devices, and is adaptable to multiple bowel preparations.

Dr. Kavathia reported having no relevant financial disclosures.

A smartphone application that provides step-by-step instructions for precolonoscopy bowel preparation appears to improve users’ bowel preparation quality, according to early findings from an ongoing study.

The Boston Bowel Preparation Scale score in 16 patients who used the doctor-designed Arizona Digestive Health App was 8.19, which was significantly better than the scores in 162 smartphone users who did not use the app (6.92) and 164 patients without smartphones (6.76). The difference in scores between the smartphone users who didn’t use the app and those without a smartphone was not statistically significant. The findings are being reported during the annual Digestive Disease Week in Orlando.

In an initial phase of the study, the 362 non–app users who underwent screening colonoscopy were simply asked whether they owned a smartphone and about their likelihood of using an app. Bowel preparation quality in those patients was evaluated by a blinded endoscopist, Dr. Nilay H. Kavathia reported during a press conference prior to the meeting

In a second phase, patients were instructed on how to download the app, which includes timed alerts with step-by-step instructions regarding dietary restrictions and use of the prep, as well as photos and tips to ensure patients’ understanding of the process, said Dr. Kavathia of the Carl T. Hayden Veterans Affairs Medical Center in Phoenix.

The information was the same as that provided in written form to those not using the app, he noted.

Bowel preparation quality in these patients was also assessed by a blinded endoscopist.

Though early, the findings are encouraging, given that the success of colonoscopy is largely based on the quality of bowel preparation achieved, Dr. Kavathia said during the press briefing.

"Basically, good colon prep is difficult to do. Inadequate preparation can result in cancellation or a compromised exam ... We believe this app provides an important step in improving patient satisfaction and harnessing technology for better health care outcomes," he added.

Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., agreed, calling the app "ingenious."

"There are a lot of barriers to success of colorectal cancer screening, and one of the main ones is ensuring that the preparation is adequate ... and everyone knows that the worst part of colonoscopy is taking the prep. Anything you can do to encourage patients to complete the prep, and perhaps enjoy doing it a little more than they generally do with the use of an app, I think that’s an ingenious approach that will improve the quality of colorectal cancer screening," he said.

The Arizona Digestive Health App is available for free for both Apple iPhone and Android devices, and is adaptable to multiple bowel preparations.

Dr. Kavathia reported having no relevant financial disclosures.

A smartphone application that provides step-by-step instructions for precolonoscopy bowel preparation appears to improve users’ bowel preparation quality, according to early findings from an ongoing study.

The Boston Bowel Preparation Scale score in 16 patients who used the doctor-designed Arizona Digestive Health App was 8.19, which was significantly better than the scores in 162 smartphone users who did not use the app (6.92) and 164 patients without smartphones (6.76). The difference in scores between the smartphone users who didn’t use the app and those without a smartphone was not statistically significant. The findings are being reported during the annual Digestive Disease Week in Orlando.

In an initial phase of the study, the 362 non–app users who underwent screening colonoscopy were simply asked whether they owned a smartphone and about their likelihood of using an app. Bowel preparation quality in those patients was evaluated by a blinded endoscopist, Dr. Nilay H. Kavathia reported during a press conference prior to the meeting

In a second phase, patients were instructed on how to download the app, which includes timed alerts with step-by-step instructions regarding dietary restrictions and use of the prep, as well as photos and tips to ensure patients’ understanding of the process, said Dr. Kavathia of the Carl T. Hayden Veterans Affairs Medical Center in Phoenix.

The information was the same as that provided in written form to those not using the app, he noted.

Bowel preparation quality in these patients was also assessed by a blinded endoscopist.

Though early, the findings are encouraging, given that the success of colonoscopy is largely based on the quality of bowel preparation achieved, Dr. Kavathia said during the press briefing.

"Basically, good colon prep is difficult to do. Inadequate preparation can result in cancellation or a compromised exam ... We believe this app provides an important step in improving patient satisfaction and harnessing technology for better health care outcomes," he added.

Dr. Larry Friedman, Digestive Disease Week Council chair and chair of the department of medicine at Newton-Wellesley Hospital in Newton, Mass., agreed, calling the app "ingenious."

"There are a lot of barriers to success of colorectal cancer screening, and one of the main ones is ensuring that the preparation is adequate ... and everyone knows that the worst part of colonoscopy is taking the prep. Anything you can do to encourage patients to complete the prep, and perhaps enjoy doing it a little more than they generally do with the use of an app, I think that’s an ingenious approach that will improve the quality of colorectal cancer screening," he said.

The Arizona Digestive Health App is available for free for both Apple iPhone and Android devices, and is adaptable to multiple bowel preparations.

Dr. Kavathia reported having no relevant financial disclosures.

INDIANAPOLIS – Robotic-assisted major pancreatic resection is safe, feasible, reliable, and versatile, according to the findings of the largest reported single-center series of such procedures.

That being said, the next and absolutely critical step needs to be comparative effectiveness studies pitting robotic versus laparoscopic or open pancreatic resections, Dr. Herbert J. Zeh III reported at the annual meeting of the American Surgical Association.

He noted that there was a considerable learning curve with the procedure in this single-center series of 250 consecutive robotic-assisted major pancreatic resections. "If we had compared our first 30, 40, or even 60 cases, we would have been comparing an innovative procedure to one that’s been refined continuously since 1937," noted Dr. Zeh of the University of Pittsburgh.

Discussants praised Dr. Zeh and his coinvestigators as innovators who are taking a rigorously scientific and cautious approach in investigating the applicability of robotic techniques to major pancreatic surgery. But some discussants were concerned that the growing dissemination of robotic surgery is based largely upon what they consider to be marketing hype and competitive pressure.

Dr. Zeh explained that he and his coworkers have undertaken the study of robotic-assisted major pancreatic resections because they believe that a minimally invasive approach will reduce the substantial morbidity traditionally associated with open procedures, and that laparoscopic techniques aren’t the answer in these complex resections, which often require resuturing the pancreas to the GI tract.

"It was our perception as a group of dedicated pancreatic surgeons that we could not utilize the laparoscopic technology to adhere to the standard principles of open surgery that we thought were important for safe performance of pancreatic resections. These include meticulous dissection, safe control of major vascular structures, and precise suturing," he said.

The 250 consecutive robotic-assisted major pancreatic resections in this series included the full range of complex pancreatic operations. The two most common procedures were pancreaticoduodenectomy, also known as the Whipple procedure, in 132 patients and distal pancreatectomy in 83.

Overall 30- and 90-day mortality rates were 0.8% and 2.0%, respectively. All deaths were in pancreaticoduodenectomy patients, with 30- and 90-day mortality rates of 1.5% and 3.8%.

Clinically significant complications occurred in 21% of patients. The most common was intra-abdominal fluid collection requiring drainage via interventional radiology. Morbidity rates were similar to those reported in large series of open and laparoscopic pancreatic resections.

Estimated blood loss in pancreaticoduodenectomy averaged 499 mL in the first one-third of patients who had the robotic procedure; thereafter, the blood loss improved to 401 mL.

Rates of conversion from robotic to open surgery also improved over time, from 18.2% in the first third of the patient series to 3.4% in the latter two-thirds.

Mean operative time was 529 minutes for pancreaticoduodenectomy and 256 minutes for distal pancreatectomy. These times have dropped steadily with experience such that mean operative time in the last 50 pancreaticoduodenectomies was 444 minutes, while in the last 50 distal pancreatectomies it was 222 minutes, which approaches reported times for laparoscopic and open operations, Dr. Zeh noted.

The median length of stay was 10 days for pancreaticoduodenectomy patients and 6 days for those undergoing distal pancreatectomy. As a precautionary measure, surgeons kept patients treated early in the series in the hospital longer than was probably necessary. Length of stay has come down over time, although this trend hasn’t yet reached statistical significance.

The readmission rate was 24% in pancreaticoduodenectomy patients and 28% in distal pancreatectomy patients; 2% of patients required a reoperation.

As experience has grown, the group’s criteria for selecting patients for the robotic approach have loosened considerably. Many recent patients have been obese or superobese.

"Currently the only absolute contraindication is some sort of vascular involvement that would entail resecting a vein and reanastomosing it using a minimally invasive approach. That’s really the only frontier we haven’t crossed," said Dr. Zeh.

The potential advantages of the robotic platform that drew the researchers’ interest include greater range of motion for the robotic needle driver and other tools, compared with what is achievable laparoscopically; enhanced visualization with magnification; computerized smoothing of a surgeon’s tremor; and the ability to see structures in three dimensions, unlike in laparoscopy.

"I think the real advantage is the computer," he added. "Robotic surgery is probably misnamed; it’s really computer-assisted surgery. What this is going to allow us to do is to take the skill sets that we have to the next level. Pilots couldn’t control fighter jets without a computer between them and the plane. In the end, I think the addition of the computer between us and the patient is going to allow us to do things that we haven’t even thought about."

He reported having received an honorarium from Medtronic on a single occasion for participation in a symposium on minimally invasive pancreatic surgery.

INDIANAPOLIS – Robotic-assisted major pancreatic resection is safe, feasible, reliable, and versatile, according to the findings of the largest reported single-center series of such procedures.

That being said, the next and absolutely critical step needs to be comparative effectiveness studies pitting robotic versus laparoscopic or open pancreatic resections, Dr. Herbert J. Zeh III reported at the annual meeting of the American Surgical Association.

He noted that there was a considerable learning curve with the procedure in this single-center series of 250 consecutive robotic-assisted major pancreatic resections. "If we had compared our first 30, 40, or even 60 cases, we would have been comparing an innovative procedure to one that’s been refined continuously since 1937," noted Dr. Zeh of the University of Pittsburgh.

Discussants praised Dr. Zeh and his coinvestigators as innovators who are taking a rigorously scientific and cautious approach in investigating the applicability of robotic techniques to major pancreatic surgery. But some discussants were concerned that the growing dissemination of robotic surgery is based largely upon what they consider to be marketing hype and competitive pressure.

Dr. Zeh explained that he and his coworkers have undertaken the study of robotic-assisted major pancreatic resections because they believe that a minimally invasive approach will reduce the substantial morbidity traditionally associated with open procedures, and that laparoscopic techniques aren’t the answer in these complex resections, which often require resuturing the pancreas to the GI tract.

"It was our perception as a group of dedicated pancreatic surgeons that we could not utilize the laparoscopic technology to adhere to the standard principles of open surgery that we thought were important for safe performance of pancreatic resections. These include meticulous dissection, safe control of major vascular structures, and precise suturing," he said.

The 250 consecutive robotic-assisted major pancreatic resections in this series included the full range of complex pancreatic operations. The two most common procedures were pancreaticoduodenectomy, also known as the Whipple procedure, in 132 patients and distal pancreatectomy in 83.

Overall 30- and 90-day mortality rates were 0.8% and 2.0%, respectively. All deaths were in pancreaticoduodenectomy patients, with 30- and 90-day mortality rates of 1.5% and 3.8%.

Clinically significant complications occurred in 21% of patients. The most common was intra-abdominal fluid collection requiring drainage via interventional radiology. Morbidity rates were similar to those reported in large series of open and laparoscopic pancreatic resections.

Estimated blood loss in pancreaticoduodenectomy averaged 499 mL in the first one-third of patients who had the robotic procedure; thereafter, the blood loss improved to 401 mL.

Rates of conversion from robotic to open surgery also improved over time, from 18.2% in the first third of the patient series to 3.4% in the latter two-thirds.

Mean operative time was 529 minutes for pancreaticoduodenectomy and 256 minutes for distal pancreatectomy. These times have dropped steadily with experience such that mean operative time in the last 50 pancreaticoduodenectomies was 444 minutes, while in the last 50 distal pancreatectomies it was 222 minutes, which approaches reported times for laparoscopic and open operations, Dr. Zeh noted.

The median length of stay was 10 days for pancreaticoduodenectomy patients and 6 days for those undergoing distal pancreatectomy. As a precautionary measure, surgeons kept patients treated early in the series in the hospital longer than was probably necessary. Length of stay has come down over time, although this trend hasn’t yet reached statistical significance.

The readmission rate was 24% in pancreaticoduodenectomy patients and 28% in distal pancreatectomy patients; 2% of patients required a reoperation.

As experience has grown, the group’s criteria for selecting patients for the robotic approach have loosened considerably. Many recent patients have been obese or superobese.

"Currently the only absolute contraindication is some sort of vascular involvement that would entail resecting a vein and reanastomosing it using a minimally invasive approach. That’s really the only frontier we haven’t crossed," said Dr. Zeh.

The potential advantages of the robotic platform that drew the researchers’ interest include greater range of motion for the robotic needle driver and other tools, compared with what is achievable laparoscopically; enhanced visualization with magnification; computerized smoothing of a surgeon’s tremor; and the ability to see structures in three dimensions, unlike in laparoscopy.

"I think the real advantage is the computer," he added. "Robotic surgery is probably misnamed; it’s really computer-assisted surgery. What this is going to allow us to do is to take the skill sets that we have to the next level. Pilots couldn’t control fighter jets without a computer between them and the plane. In the end, I think the addition of the computer between us and the patient is going to allow us to do things that we haven’t even thought about."

He reported having received an honorarium from Medtronic on a single occasion for participation in a symposium on minimally invasive pancreatic surgery.

INDIANAPOLIS – Robotic-assisted major pancreatic resection is safe, feasible, reliable, and versatile, according to the findings of the largest reported single-center series of such procedures.

That being said, the next and absolutely critical step needs to be comparative effectiveness studies pitting robotic versus laparoscopic or open pancreatic resections, Dr. Herbert J. Zeh III reported at the annual meeting of the American Surgical Association.

He noted that there was a considerable learning curve with the procedure in this single-center series of 250 consecutive robotic-assisted major pancreatic resections. "If we had compared our first 30, 40, or even 60 cases, we would have been comparing an innovative procedure to one that’s been refined continuously since 1937," noted Dr. Zeh of the University of Pittsburgh.

Discussants praised Dr. Zeh and his coinvestigators as innovators who are taking a rigorously scientific and cautious approach in investigating the applicability of robotic techniques to major pancreatic surgery. But some discussants were concerned that the growing dissemination of robotic surgery is based largely upon what they consider to be marketing hype and competitive pressure.

Dr. Zeh explained that he and his coworkers have undertaken the study of robotic-assisted major pancreatic resections because they believe that a minimally invasive approach will reduce the substantial morbidity traditionally associated with open procedures, and that laparoscopic techniques aren’t the answer in these complex resections, which often require resuturing the pancreas to the GI tract.

"It was our perception as a group of dedicated pancreatic surgeons that we could not utilize the laparoscopic technology to adhere to the standard principles of open surgery that we thought were important for safe performance of pancreatic resections. These include meticulous dissection, safe control of major vascular structures, and precise suturing," he said.

The 250 consecutive robotic-assisted major pancreatic resections in this series included the full range of complex pancreatic operations. The two most common procedures were pancreaticoduodenectomy, also known as the Whipple procedure, in 132 patients and distal pancreatectomy in 83.

Overall 30- and 90-day mortality rates were 0.8% and 2.0%, respectively. All deaths were in pancreaticoduodenectomy patients, with 30- and 90-day mortality rates of 1.5% and 3.8%.

Clinically significant complications occurred in 21% of patients. The most common was intra-abdominal fluid collection requiring drainage via interventional radiology. Morbidity rates were similar to those reported in large series of open and laparoscopic pancreatic resections.

Estimated blood loss in pancreaticoduodenectomy averaged 499 mL in the first one-third of patients who had the robotic procedure; thereafter, the blood loss improved to 401 mL.

Rates of conversion from robotic to open surgery also improved over time, from 18.2% in the first third of the patient series to 3.4% in the latter two-thirds.

Mean operative time was 529 minutes for pancreaticoduodenectomy and 256 minutes for distal pancreatectomy. These times have dropped steadily with experience such that mean operative time in the last 50 pancreaticoduodenectomies was 444 minutes, while in the last 50 distal pancreatectomies it was 222 minutes, which approaches reported times for laparoscopic and open operations, Dr. Zeh noted.

The median length of stay was 10 days for pancreaticoduodenectomy patients and 6 days for those undergoing distal pancreatectomy. As a precautionary measure, surgeons kept patients treated early in the series in the hospital longer than was probably necessary. Length of stay has come down over time, although this trend hasn’t yet reached statistical significance.

The readmission rate was 24% in pancreaticoduodenectomy patients and 28% in distal pancreatectomy patients; 2% of patients required a reoperation.

As experience has grown, the group’s criteria for selecting patients for the robotic approach have loosened considerably. Many recent patients have been obese or superobese.

"Currently the only absolute contraindication is some sort of vascular involvement that would entail resecting a vein and reanastomosing it using a minimally invasive approach. That’s really the only frontier we haven’t crossed," said Dr. Zeh.

The potential advantages of the robotic platform that drew the researchers’ interest include greater range of motion for the robotic needle driver and other tools, compared with what is achievable laparoscopically; enhanced visualization with magnification; computerized smoothing of a surgeon’s tremor; and the ability to see structures in three dimensions, unlike in laparoscopy.

"I think the real advantage is the computer," he added. "Robotic surgery is probably misnamed; it’s really computer-assisted surgery. What this is going to allow us to do is to take the skill sets that we have to the next level. Pilots couldn’t control fighter jets without a computer between them and the plane. In the end, I think the addition of the computer between us and the patient is going to allow us to do things that we haven’t even thought about."

He reported having received an honorarium from Medtronic on a single occasion for participation in a symposium on minimally invasive pancreatic surgery.

BRUSSELS – When biopsying a primary breast cancer, once is probably not enough based on accumulating evidence of primary-tumor heterogeneity, but despite this evidence, taking multiple biopsies has not yet become routine practice.

"Intra-tumor heterogeneity is one of the causes of variation during genetic profiling" of tumors, Dr. Jorge S. Reis-Fiho said. "Taking multiple biopsies from a primary tumor and putting them all together may mitigate the effect of intra-tumor heterogeneity," but taking multiple biopsies has not yet become standard of care, he said at the conference, which was sponsored by the European Society for Medical Oncology.

Mitchel L. Zoler/IMNG Medical Media

"I think we should start to seriously consider taking more than one biopsy. Quite a few places already do it, and our radiologists will routinely take two or three biopsies," said Dr. Fiho, a surgical pathologist at Memorial Sloan-Kettering Cancer Center in New York. "With only a single, small biopsy of the primary tumor we may not have sufficient information to predict what the metastasis will respond to," he said in an interview.

Results from two studies reported at the meeting added to the evidence favoring multiple biopsies as a way to more precisely characterize primary tumors and target the best therapy.

In one study, Dr. Michal Jarzab and his associates took three core biopsies from the primary tumors of 26 patients and assessed them genetically for estrogen receptor, progesterone receptor, and HER2-receptor mutations. Their sample included some patients with early-stage disease and others with advanced-stage cancer. The results of the three individual biopsy tests showed significant heterogeneity in seven of the 26 tumors (27%), reported Dr. Jarzab, a researcher at the Maria Sklodowska-Curie Cancer Center and Institute of Oncology in Gliwice, Poland.

The intratumor heterogeneity in these seven patients "could negatively impact genomic assessment if done with one specimen," he said.

"If other studies report similar results" on intratumor heterogeneity, "then it could become common practice to evaluate prognostic or predictive breast cancer markers from more than one primary tumour area," Dr. Angelo Di Leo, chairman of oncology at Prato (Italy) Hospital, said in a written statement.

The second study looked at the impact of assessing one, two, or three biopsies on the variance in results from four different single- or multiple-genetic tests in biopsies collected from 51 breast cancer patients. The amount of variance depended on the gene or genes tested, but, overall, using three biopsy specimens rather than one substantially reduced the variance, reported Dr. Rosanna Lau, a researcher at the University of Texas M.D. Anderson Cancer Center in Houston.

"Pooling biopsies from a single tumor reduced outlier results and reduced variance more generally for certain genes," Dr. Lau said. "Pooling biopsies is usually preferable to a single biopsy." The results showed that "we can get a comprehensive picture of the genes being expressed in the tumor by sampling multiple areas of the tumor and pooling the samples together. This increases the precision of the assay and allows us to make more reliable predictions related to the disease," she said in a written statement.

Her study also looked at the scope of analytic variance – variance caused by technical issues – in the biopsies taken from a 20-patient subgroup and found that the extent of analytic variance also varied by gene and was generally of the same magnitude as intratumor heterogeneity. The analytic variance wasn’t helped by pooling multiple biopsies, but data-processing solutions such as normalizing and scaling reduced this part of the variance, Dr. Lau said.

Dr. Reis-Fiho, Dr. Lau, Dr. Jarzab, and Dr. Di Leo had no disclosures.

[email protected]

BRUSSELS – When biopsying a primary breast cancer, once is probably not enough based on accumulating evidence of primary-tumor heterogeneity, but despite this evidence, taking multiple biopsies has not yet become routine practice.

"Intra-tumor heterogeneity is one of the causes of variation during genetic profiling" of tumors, Dr. Jorge S. Reis-Fiho said. "Taking multiple biopsies from a primary tumor and putting them all together may mitigate the effect of intra-tumor heterogeneity," but taking multiple biopsies has not yet become standard of care, he said at the conference, which was sponsored by the European Society for Medical Oncology.

Mitchel L. Zoler/IMNG Medical Media

"I think we should start to seriously consider taking more than one biopsy. Quite a few places already do it, and our radiologists will routinely take two or three biopsies," said Dr. Fiho, a surgical pathologist at Memorial Sloan-Kettering Cancer Center in New York. "With only a single, small biopsy of the primary tumor we may not have sufficient information to predict what the metastasis will respond to," he said in an interview.

Results from two studies reported at the meeting added to the evidence favoring multiple biopsies as a way to more precisely characterize primary tumors and target the best therapy.

In one study, Dr. Michal Jarzab and his associates took three core biopsies from the primary tumors of 26 patients and assessed them genetically for estrogen receptor, progesterone receptor, and HER2-receptor mutations. Their sample included some patients with early-stage disease and others with advanced-stage cancer. The results of the three individual biopsy tests showed significant heterogeneity in seven of the 26 tumors (27%), reported Dr. Jarzab, a researcher at the Maria Sklodowska-Curie Cancer Center and Institute of Oncology in Gliwice, Poland.

The intratumor heterogeneity in these seven patients "could negatively impact genomic assessment if done with one specimen," he said.

"If other studies report similar results" on intratumor heterogeneity, "then it could become common practice to evaluate prognostic or predictive breast cancer markers from more than one primary tumour area," Dr. Angelo Di Leo, chairman of oncology at Prato (Italy) Hospital, said in a written statement.

The second study looked at the impact of assessing one, two, or three biopsies on the variance in results from four different single- or multiple-genetic tests in biopsies collected from 51 breast cancer patients. The amount of variance depended on the gene or genes tested, but, overall, using three biopsy specimens rather than one substantially reduced the variance, reported Dr. Rosanna Lau, a researcher at the University of Texas M.D. Anderson Cancer Center in Houston.

"Pooling biopsies from a single tumor reduced outlier results and reduced variance more generally for certain genes," Dr. Lau said. "Pooling biopsies is usually preferable to a single biopsy." The results showed that "we can get a comprehensive picture of the genes being expressed in the tumor by sampling multiple areas of the tumor and pooling the samples together. This increases the precision of the assay and allows us to make more reliable predictions related to the disease," she said in a written statement.

Her study also looked at the scope of analytic variance – variance caused by technical issues – in the biopsies taken from a 20-patient subgroup and found that the extent of analytic variance also varied by gene and was generally of the same magnitude as intratumor heterogeneity. The analytic variance wasn’t helped by pooling multiple biopsies, but data-processing solutions such as normalizing and scaling reduced this part of the variance, Dr. Lau said.

Dr. Reis-Fiho, Dr. Lau, Dr. Jarzab, and Dr. Di Leo had no disclosures.

[email protected]

BRUSSELS – When biopsying a primary breast cancer, once is probably not enough based on accumulating evidence of primary-tumor heterogeneity, but despite this evidence, taking multiple biopsies has not yet become routine practice.

"Intra-tumor heterogeneity is one of the causes of variation during genetic profiling" of tumors, Dr. Jorge S. Reis-Fiho said. "Taking multiple biopsies from a primary tumor and putting them all together may mitigate the effect of intra-tumor heterogeneity," but taking multiple biopsies has not yet become standard of care, he said at the conference, which was sponsored by the European Society for Medical Oncology.

Mitchel L. Zoler/IMNG Medical Media

"I think we should start to seriously consider taking more than one biopsy. Quite a few places already do it, and our radiologists will routinely take two or three biopsies," said Dr. Fiho, a surgical pathologist at Memorial Sloan-Kettering Cancer Center in New York. "With only a single, small biopsy of the primary tumor we may not have sufficient information to predict what the metastasis will respond to," he said in an interview.

Results from two studies reported at the meeting added to the evidence favoring multiple biopsies as a way to more precisely characterize primary tumors and target the best therapy.

In one study, Dr. Michal Jarzab and his associates took three core biopsies from the primary tumors of 26 patients and assessed them genetically for estrogen receptor, progesterone receptor, and HER2-receptor mutations. Their sample included some patients with early-stage disease and others with advanced-stage cancer. The results of the three individual biopsy tests showed significant heterogeneity in seven of the 26 tumors (27%), reported Dr. Jarzab, a researcher at the Maria Sklodowska-Curie Cancer Center and Institute of Oncology in Gliwice, Poland.

The intratumor heterogeneity in these seven patients "could negatively impact genomic assessment if done with one specimen," he said.

"If other studies report similar results" on intratumor heterogeneity, "then it could become common practice to evaluate prognostic or predictive breast cancer markers from more than one primary tumour area," Dr. Angelo Di Leo, chairman of oncology at Prato (Italy) Hospital, said in a written statement.

The second study looked at the impact of assessing one, two, or three biopsies on the variance in results from four different single- or multiple-genetic tests in biopsies collected from 51 breast cancer patients. The amount of variance depended on the gene or genes tested, but, overall, using three biopsy specimens rather than one substantially reduced the variance, reported Dr. Rosanna Lau, a researcher at the University of Texas M.D. Anderson Cancer Center in Houston.

"Pooling biopsies from a single tumor reduced outlier results and reduced variance more generally for certain genes," Dr. Lau said. "Pooling biopsies is usually preferable to a single biopsy." The results showed that "we can get a comprehensive picture of the genes being expressed in the tumor by sampling multiple areas of the tumor and pooling the samples together. This increases the precision of the assay and allows us to make more reliable predictions related to the disease," she said in a written statement.

Her study also looked at the scope of analytic variance – variance caused by technical issues – in the biopsies taken from a 20-patient subgroup and found that the extent of analytic variance also varied by gene and was generally of the same magnitude as intratumor heterogeneity. The analytic variance wasn’t helped by pooling multiple biopsies, but data-processing solutions such as normalizing and scaling reduced this part of the variance, Dr. Lau said.

Dr. Reis-Fiho, Dr. Lau, Dr. Jarzab, and Dr. Di Leo had no disclosures.

[email protected]

MINNEAPOLIS – Minimal-dose computed tomography was superior to chest radiographs for surveillance after curative lung cancer resection in a randomized controlled trial involving over 300 patients.

"Minimal-dose CT should be the modality of choice for surveillance after resection of lung cancer," Dr. Waël Hanna said at the annual meeting of the American Association for Thoracic Surgery.

Copyright Martin Allred

Repeated radiation exposure and a high false-positive rate have been stumbling blocks to national lung cancer screening with low-dose spiral CT, despite the technology demonstrating 20% fewer lung cancer deaths compared with chest x-ray in asymptomatic heavy smokers in the National Lung Cancer Screening Trial (NLST). Minimal-dose CT of the chest delivers a radiation dose of 0.2 mSv per scan, which is comparable to chest x-ray at 0.16 mSv and lower than a diagnostic CT or low-dose CT at roughly 8 mSv and 1.5 mSv, he said.

The 311 patients in the current study were prospectively enrolled after curative resection and underwent minimal-dose CT and chest x-ray at 3, 6, 12, 18, 24, 36, 48, and 60 months. A total of 1,137 pairs of chest X-ray and CT scans were analyzed by radiologists blinded to the other modality.

Minimal-dose CT detected 94.2% of the new or recurrent lung cancer, compared with 21.1% for chest x-ray (P value .0001), said Dr. Hanna, a thoracic surgery fellow at the University of Toronto.

The increased sensitivity came at a cost of significantly lower specificity (86% vs. 99.9%) and positive predictive value (25.1% vs. 91.6%; both P less than .0001). The negative predictive value for minimal-dose CT, however, was almost perfect (99.7% vs. 96.1%; P = .007).

More importantly, of the 63 patients diagnosed with new or recurrent cancer, 49 (78%) had asymptomatic disease detected only on minimal dose CT, Dr. Hanna said. Two-thirds of the asymptomatic patients were diagnosed within the first year of surveillance and 94% within 2 years of initial surgery.

"Why is this important? Because when you find it at an earlier stage, earlier in time, you can do something about it," he said.

Asymptomatic patients who were restaged and given curative surgery or radiation went on to live a median of 69 months (range, 12-76) after the initial operation, compared with a median survival of 25 months (range, 6-48) among asymptomatic patients given palliative treatment after restaging (P less than .001).

The 14 patients with symptomatic recurrent or new cancer had a median survival of only 15 months (range, 7-63) with palliative care.

"We are not saying that minimal-dose CT improves survival because these two patient populations are different," Dr. Hanna said. "The patient who presents with asymptomatic disease of the chest and is a candidate for surgery is clearly different from the patient who presents with brain metastases and is symptomatic. But follow-up with minimal-dose CT allows us to identify this cohort of patients in whom close surveillance after surgery is not futile, in whom close surveillance after surgery is amenable to intervention and treatment, and is associated with long survival."

Several prominent guidelines, including those from the AATS and National Comprehensive Cancer Network, have moved to include regular CT scans in the wake of the NLST, but evidence is lacking to suggest that earlier treatment of recurrence leads to better outcomes.

Invited discussant Dr. Michael Jaklitsch of Brigham and Women’s Hospital, Boston, said that the investigators were able to take a group of patients who would have had a 5-year survival of 50% and raise it to 75% through aggressive surveillance and show that they were "truly curing" these patients.

"Is this enough data to change our personal practices today," he posited. "For me personally, the answer is yes. This single paper presents me with enough data to say I will use minimal-dose CT scan as my sole method of screening for recurrence of early-stage lung cancer moving forward."

Dr. Jaklitsch questioned whether there were subpopulations in whom minimal-dose CT would not work, such as the obese or those with surgical clips. Dr. Hanna said that radiologists at his center are more comfortable using low-dose CT for surveillance because of the risk of scatter in either of these subgroups or in those with mediastinal involvement.

Dr. Hanna also noted that minimal-dose CT is not available everywhere, but Dr. Jaklitsch said that he took the specifications from the paper to his community hospital and they said they could be done. "So at least in the U.S., this will have dramatic penetrance," he added.

Copyright Martin Allred

New AATS president David Sugarbaker, chief of thoracic surgery at Brigham and Women’s Hospital and the Richard E. Wilson Professor of Surgical Oncology at Harvard Medical School, Boston, was not convinced, and suggested that the study essentially describes the detection of new primary tumors following initial resection.

"It’s important to realize that what you’re really talking about is screening patients who’ve had lobar resection for lung cancer," Dr. Sugarbaker said.

"So, I’m not sure you’re conclusion about follow-up detection of metastatic disease is really an accurate description as to what you’ve done, particularly with the inability of minimal-dose CT to assess the mediastinal. Particularly in the larger lesions, where distant metastatic disease may be more frequent, I’m not sure that minimal dose CT is adequate for those patients, where again, mediastinal disease can be the real issue," he said.

Dr. Hanna said that they realize these patients are also at risk of mediastinal disease and that the future will include a more patient-centered approach to surveillance in which patients with a higher risk of distant recurrence will have some other test on top of minimal-dose CT.

Dr. Hanna and his coauthors reported having no study sponsorship or financial disclosures.

[email protected]

MINNEAPOLIS – Minimal-dose computed tomography was superior to chest radiographs for surveillance after curative lung cancer resection in a randomized controlled trial involving over 300 patients.

"Minimal-dose CT should be the modality of choice for surveillance after resection of lung cancer," Dr. Waël Hanna said at the annual meeting of the American Association for Thoracic Surgery.

Copyright Martin Allred

Repeated radiation exposure and a high false-positive rate have been stumbling blocks to national lung cancer screening with low-dose spiral CT, despite the technology demonstrating 20% fewer lung cancer deaths compared with chest x-ray in asymptomatic heavy smokers in the National Lung Cancer Screening Trial (NLST). Minimal-dose CT of the chest delivers a radiation dose of 0.2 mSv per scan, which is comparable to chest x-ray at 0.16 mSv and lower than a diagnostic CT or low-dose CT at roughly 8 mSv and 1.5 mSv, he said.

The 311 patients in the current study were prospectively enrolled after curative resection and underwent minimal-dose CT and chest x-ray at 3, 6, 12, 18, 24, 36, 48, and 60 months. A total of 1,137 pairs of chest X-ray and CT scans were analyzed by radiologists blinded to the other modality.

Minimal-dose CT detected 94.2% of the new or recurrent lung cancer, compared with 21.1% for chest x-ray (P value .0001), said Dr. Hanna, a thoracic surgery fellow at the University of Toronto.

The increased sensitivity came at a cost of significantly lower specificity (86% vs. 99.9%) and positive predictive value (25.1% vs. 91.6%; both P less than .0001). The negative predictive value for minimal-dose CT, however, was almost perfect (99.7% vs. 96.1%; P = .007).

More importantly, of the 63 patients diagnosed with new or recurrent cancer, 49 (78%) had asymptomatic disease detected only on minimal dose CT, Dr. Hanna said. Two-thirds of the asymptomatic patients were diagnosed within the first year of surveillance and 94% within 2 years of initial surgery.

"Why is this important? Because when you find it at an earlier stage, earlier in time, you can do something about it," he said.

Asymptomatic patients who were restaged and given curative surgery or radiation went on to live a median of 69 months (range, 12-76) after the initial operation, compared with a median survival of 25 months (range, 6-48) among asymptomatic patients given palliative treatment after restaging (P less than .001).

The 14 patients with symptomatic recurrent or new cancer had a median survival of only 15 months (range, 7-63) with palliative care.

"We are not saying that minimal-dose CT improves survival because these two patient populations are different," Dr. Hanna said. "The patient who presents with asymptomatic disease of the chest and is a candidate for surgery is clearly different from the patient who presents with brain metastases and is symptomatic. But follow-up with minimal-dose CT allows us to identify this cohort of patients in whom close surveillance after surgery is not futile, in whom close surveillance after surgery is amenable to intervention and treatment, and is associated with long survival."

Several prominent guidelines, including those from the AATS and National Comprehensive Cancer Network, have moved to include regular CT scans in the wake of the NLST, but evidence is lacking to suggest that earlier treatment of recurrence leads to better outcomes.

Invited discussant Dr. Michael Jaklitsch of Brigham and Women’s Hospital, Boston, said that the investigators were able to take a group of patients who would have had a 5-year survival of 50% and raise it to 75% through aggressive surveillance and show that they were "truly curing" these patients.

"Is this enough data to change our personal practices today," he posited. "For me personally, the answer is yes. This single paper presents me with enough data to say I will use minimal-dose CT scan as my sole method of screening for recurrence of early-stage lung cancer moving forward."

Dr. Jaklitsch questioned whether there were subpopulations in whom minimal-dose CT would not work, such as the obese or those with surgical clips. Dr. Hanna said that radiologists at his center are more comfortable using low-dose CT for surveillance because of the risk of scatter in either of these subgroups or in those with mediastinal involvement.

Dr. Hanna also noted that minimal-dose CT is not available everywhere, but Dr. Jaklitsch said that he took the specifications from the paper to his community hospital and they said they could be done. "So at least in the U.S., this will have dramatic penetrance," he added.

Copyright Martin Allred

New AATS president David Sugarbaker, chief of thoracic surgery at Brigham and Women’s Hospital and the Richard E. Wilson Professor of Surgical Oncology at Harvard Medical School, Boston, was not convinced, and suggested that the study essentially describes the detection of new primary tumors following initial resection.

"It’s important to realize that what you’re really talking about is screening patients who’ve had lobar resection for lung cancer," Dr. Sugarbaker said.

"So, I’m not sure you’re conclusion about follow-up detection of metastatic disease is really an accurate description as to what you’ve done, particularly with the inability of minimal-dose CT to assess the mediastinal. Particularly in the larger lesions, where distant metastatic disease may be more frequent, I’m not sure that minimal dose CT is adequate for those patients, where again, mediastinal disease can be the real issue," he said.

Dr. Hanna said that they realize these patients are also at risk of mediastinal disease and that the future will include a more patient-centered approach to surveillance in which patients with a higher risk of distant recurrence will have some other test on top of minimal-dose CT.

Dr. Hanna and his coauthors reported having no study sponsorship or financial disclosures.

[email protected]

MINNEAPOLIS – Minimal-dose computed tomography was superior to chest radiographs for surveillance after curative lung cancer resection in a randomized controlled trial involving over 300 patients.

"Minimal-dose CT should be the modality of choice for surveillance after resection of lung cancer," Dr. Waël Hanna said at the annual meeting of the American Association for Thoracic Surgery.

Copyright Martin Allred

Repeated radiation exposure and a high false-positive rate have been stumbling blocks to national lung cancer screening with low-dose spiral CT, despite the technology demonstrating 20% fewer lung cancer deaths compared with chest x-ray in asymptomatic heavy smokers in the National Lung Cancer Screening Trial (NLST). Minimal-dose CT of the chest delivers a radiation dose of 0.2 mSv per scan, which is comparable to chest x-ray at 0.16 mSv and lower than a diagnostic CT or low-dose CT at roughly 8 mSv and 1.5 mSv, he said.

The 311 patients in the current study were prospectively enrolled after curative resection and underwent minimal-dose CT and chest x-ray at 3, 6, 12, 18, 24, 36, 48, and 60 months. A total of 1,137 pairs of chest X-ray and CT scans were analyzed by radiologists blinded to the other modality.

Minimal-dose CT detected 94.2% of the new or recurrent lung cancer, compared with 21.1% for chest x-ray (P value .0001), said Dr. Hanna, a thoracic surgery fellow at the University of Toronto.

The increased sensitivity came at a cost of significantly lower specificity (86% vs. 99.9%) and positive predictive value (25.1% vs. 91.6%; both P less than .0001). The negative predictive value for minimal-dose CT, however, was almost perfect (99.7% vs. 96.1%; P = .007).

More importantly, of the 63 patients diagnosed with new or recurrent cancer, 49 (78%) had asymptomatic disease detected only on minimal dose CT, Dr. Hanna said. Two-thirds of the asymptomatic patients were diagnosed within the first year of surveillance and 94% within 2 years of initial surgery.

"Why is this important? Because when you find it at an earlier stage, earlier in time, you can do something about it," he said.

Asymptomatic patients who were restaged and given curative surgery or radiation went on to live a median of 69 months (range, 12-76) after the initial operation, compared with a median survival of 25 months (range, 6-48) among asymptomatic patients given palliative treatment after restaging (P less than .001).

The 14 patients with symptomatic recurrent or new cancer had a median survival of only 15 months (range, 7-63) with palliative care.

"We are not saying that minimal-dose CT improves survival because these two patient populations are different," Dr. Hanna said. "The patient who presents with asymptomatic disease of the chest and is a candidate for surgery is clearly different from the patient who presents with brain metastases and is symptomatic. But follow-up with minimal-dose CT allows us to identify this cohort of patients in whom close surveillance after surgery is not futile, in whom close surveillance after surgery is amenable to intervention and treatment, and is associated with long survival."

Several prominent guidelines, including those from the AATS and National Comprehensive Cancer Network, have moved to include regular CT scans in the wake of the NLST, but evidence is lacking to suggest that earlier treatment of recurrence leads to better outcomes.

Invited discussant Dr. Michael Jaklitsch of Brigham and Women’s Hospital, Boston, said that the investigators were able to take a group of patients who would have had a 5-year survival of 50% and raise it to 75% through aggressive surveillance and show that they were "truly curing" these patients.

"Is this enough data to change our personal practices today," he posited. "For me personally, the answer is yes. This single paper presents me with enough data to say I will use minimal-dose CT scan as my sole method of screening for recurrence of early-stage lung cancer moving forward."

Dr. Jaklitsch questioned whether there were subpopulations in whom minimal-dose CT would not work, such as the obese or those with surgical clips. Dr. Hanna said that radiologists at his center are more comfortable using low-dose CT for surveillance because of the risk of scatter in either of these subgroups or in those with mediastinal involvement.

Dr. Hanna also noted that minimal-dose CT is not available everywhere, but Dr. Jaklitsch said that he took the specifications from the paper to his community hospital and they said they could be done. "So at least in the U.S., this will have dramatic penetrance," he added.

Copyright Martin Allred

New AATS president David Sugarbaker, chief of thoracic surgery at Brigham and Women’s Hospital and the Richard E. Wilson Professor of Surgical Oncology at Harvard Medical School, Boston, was not convinced, and suggested that the study essentially describes the detection of new primary tumors following initial resection.

"It’s important to realize that what you’re really talking about is screening patients who’ve had lobar resection for lung cancer," Dr. Sugarbaker said.

"So, I’m not sure you’re conclusion about follow-up detection of metastatic disease is really an accurate description as to what you’ve done, particularly with the inability of minimal-dose CT to assess the mediastinal. Particularly in the larger lesions, where distant metastatic disease may be more frequent, I’m not sure that minimal dose CT is adequate for those patients, where again, mediastinal disease can be the real issue," he said.

Dr. Hanna said that they realize these patients are also at risk of mediastinal disease and that the future will include a more patient-centered approach to surveillance in which patients with a higher risk of distant recurrence will have some other test on top of minimal-dose CT.

Dr. Hanna and his coauthors reported having no study sponsorship or financial disclosures.

[email protected]

For the first time in 7 years, the Centers for Medicare and Medicaid Services has a Senate-confirmed administrator, now that Marilyn Tavenner has received that body’s stamp of approval.

Ms. Tavenner was confirmed on May 15 by a 91-7 vote (two senators did not vote). The Republican senators opposing her confirmation were Mike Crapo of Idaho, Ted Cruz of Texas, Ron Johnson of Wisconsin, Mike Lee of Utah, Mitch McConnell of Kentucky, Rand Paul of Kentucky, and James Risch of Idaho.

Ms. Tavenner has been serving as acting administrator since December 2011, when Dr. Don Berwick stepped down.

"Marilyn brings with her a breadth of experience and expertise from virtually all angles of health care policy and delivery, having served as a hospital CEO, a state health official, and a registered nurse," Kathleen Sebelius, Health and Human Services Secretary, said in a statement. "Marilyn will serve in a critical role at CMS as we work to improve the health care for hundreds of millions of Americans."

Ms. Tavenner has said that she wants the agency to evolve into something a bit different under her leadership. In a written response to questions during her confirmation process, she said that she will have three primary aims.

First "we need to operate CMS as a business and act like business partners," she wrote. That includes "an ‘open-door policy’ to work together and listen to the concerns of all the groups we work with and work for: beneficiaries, taxpayers, providers, hospitals, members of Congress, states, advocacy groups, insurance companies and our own employees and contractors."

The second aim is implementing the ACA and the third is to use new tools to reduce health costs and improve delivery.

"These tools include new payment strategies connected to performance, new models of care, and enhanced tools to combat fraud," she wrote.

Ms. Tavenner has generally been well regarded among physicians and other health care providers, and they applauded her confirmation.

"The American Medical Association is very pleased that the Senate has confirmed Marilyn Tavenner as administrator of CMS," Dr. Jeremy Lazarus, president of the AMA, said in a statement. "As acting administrator, she has demonstrated her ability to be a capable and effective leader. We look forward to continuing to work with the administrator to strengthen the Medicare system to improve health outcomes for patients and the practice environment for physicians."

The American Society of Clinical Oncology also issued a statement of support, noting that the agency was at a critical point.

"CMS faces many challenges in the coming months that will impact oncologists and their patients," Dr. Sandra Swain, ASCO president, said in a statement. "ASCO encourages Administrator Tavenner to continue working closely with the cancer community specifically as it works to develop a system to qualify registry programs, such as the Quality Oncology Practice Initiative (QOPI), for reporting under the Physician Quality Reporting System (PQRS)," she said.

Prior to joining the federal government, Ms. Tavenner worked extensively for the Hospital Corporation of America and served as the company’s group president of outpatient services just prior to leaving in 2005. She is a registered nurse and received both her nursing degree and master’s of health administration from Virginia Commonwealth University.

[email protected]

On Twitter @aliciaault

For the first time in 7 years, the Centers for Medicare and Medicaid Services has a Senate-confirmed administrator, now that Marilyn Tavenner has received that body’s stamp of approval.

Ms. Tavenner was confirmed on May 15 by a 91-7 vote (two senators did not vote). The Republican senators opposing her confirmation were Mike Crapo of Idaho, Ted Cruz of Texas, Ron Johnson of Wisconsin, Mike Lee of Utah, Mitch McConnell of Kentucky, Rand Paul of Kentucky, and James Risch of Idaho.

Ms. Tavenner has been serving as acting administrator since December 2011, when Dr. Don Berwick stepped down.

"Marilyn brings with her a breadth of experience and expertise from virtually all angles of health care policy and delivery, having served as a hospital CEO, a state health official, and a registered nurse," Kathleen Sebelius, Health and Human Services Secretary, said in a statement. "Marilyn will serve in a critical role at CMS as we work to improve the health care for hundreds of millions of Americans."

Ms. Tavenner has said that she wants the agency to evolve into something a bit different under her leadership. In a written response to questions during her confirmation process, she said that she will have three primary aims.

First "we need to operate CMS as a business and act like business partners," she wrote. That includes "an ‘open-door policy’ to work together and listen to the concerns of all the groups we work with and work for: beneficiaries, taxpayers, providers, hospitals, members of Congress, states, advocacy groups, insurance companies and our own employees and contractors."

The second aim is implementing the ACA and the third is to use new tools to reduce health costs and improve delivery.

"These tools include new payment strategies connected to performance, new models of care, and enhanced tools to combat fraud," she wrote.

Ms. Tavenner has generally been well regarded among physicians and other health care providers, and they applauded her confirmation.

"The American Medical Association is very pleased that the Senate has confirmed Marilyn Tavenner as administrator of CMS," Dr. Jeremy Lazarus, president of the AMA, said in a statement. "As acting administrator, she has demonstrated her ability to be a capable and effective leader. We look forward to continuing to work with the administrator to strengthen the Medicare system to improve health outcomes for patients and the practice environment for physicians."

The American Society of Clinical Oncology also issued a statement of support, noting that the agency was at a critical point.

"CMS faces many challenges in the coming months that will impact oncologists and their patients," Dr. Sandra Swain, ASCO president, said in a statement. "ASCO encourages Administrator Tavenner to continue working closely with the cancer community specifically as it works to develop a system to qualify registry programs, such as the Quality Oncology Practice Initiative (QOPI), for reporting under the Physician Quality Reporting System (PQRS)," she said.

Prior to joining the federal government, Ms. Tavenner worked extensively for the Hospital Corporation of America and served as the company’s group president of outpatient services just prior to leaving in 2005. She is a registered nurse and received both her nursing degree and master’s of health administration from Virginia Commonwealth University.

[email protected]

On Twitter @aliciaault

For the first time in 7 years, the Centers for Medicare and Medicaid Services has a Senate-confirmed administrator, now that Marilyn Tavenner has received that body’s stamp of approval.

Ms. Tavenner was confirmed on May 15 by a 91-7 vote (two senators did not vote). The Republican senators opposing her confirmation were Mike Crapo of Idaho, Ted Cruz of Texas, Ron Johnson of Wisconsin, Mike Lee of Utah, Mitch McConnell of Kentucky, Rand Paul of Kentucky, and James Risch of Idaho.

Ms. Tavenner has been serving as acting administrator since December 2011, when Dr. Don Berwick stepped down.

"Marilyn brings with her a breadth of experience and expertise from virtually all angles of health care policy and delivery, having served as a hospital CEO, a state health official, and a registered nurse," Kathleen Sebelius, Health and Human Services Secretary, said in a statement. "Marilyn will serve in a critical role at CMS as we work to improve the health care for hundreds of millions of Americans."

Ms. Tavenner has said that she wants the agency to evolve into something a bit different under her leadership. In a written response to questions during her confirmation process, she said that she will have three primary aims.

First "we need to operate CMS as a business and act like business partners," she wrote. That includes "an ‘open-door policy’ to work together and listen to the concerns of all the groups we work with and work for: beneficiaries, taxpayers, providers, hospitals, members of Congress, states, advocacy groups, insurance companies and our own employees and contractors."

The second aim is implementing the ACA and the third is to use new tools to reduce health costs and improve delivery.

"These tools include new payment strategies connected to performance, new models of care, and enhanced tools to combat fraud," she wrote.

Ms. Tavenner has generally been well regarded among physicians and other health care providers, and they applauded her confirmation.

"The American Medical Association is very pleased that the Senate has confirmed Marilyn Tavenner as administrator of CMS," Dr. Jeremy Lazarus, president of the AMA, said in a statement. "As acting administrator, she has demonstrated her ability to be a capable and effective leader. We look forward to continuing to work with the administrator to strengthen the Medicare system to improve health outcomes for patients and the practice environment for physicians."

The American Society of Clinical Oncology also issued a statement of support, noting that the agency was at a critical point.

"CMS faces many challenges in the coming months that will impact oncologists and their patients," Dr. Sandra Swain, ASCO president, said in a statement. "ASCO encourages Administrator Tavenner to continue working closely with the cancer community specifically as it works to develop a system to qualify registry programs, such as the Quality Oncology Practice Initiative (QOPI), for reporting under the Physician Quality Reporting System (PQRS)," she said.

Prior to joining the federal government, Ms. Tavenner worked extensively for the Hospital Corporation of America and served as the company’s group president of outpatient services just prior to leaving in 2005. She is a registered nurse and received both her nursing degree and master’s of health administration from Virginia Commonwealth University.

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