Endoscopy, Pancreas, & Biliary Tract

SAN DIEGO – Taking selective serotonin reuptake inhibitors (SSRIs) was not associated with an increased risk of endoscopy-refractory bleeding, rebleeding, or in-hospital mortality among 14,343 consecutive patients admitted with bleeding peptic ulcer in Denmark.

The study suggests that patients with bleeding peptic ulcers can “continue SSRI treatment if the treatment is well indicated,” and that these patients can otherwise receive treatment similar to that of other patients with peptic ulcer bleeding, Dr. Stig B. Laursen reported at the annual Digestive Disease Week.

Observational research has linked use of SSRI antidepressants to an approximately 1.5-fold increase in upper GI bleeding in peptic ulcer bleeding cases, said Dr. Laursen of Odense (Denmark) University Hospital. Studies, mostly in vitro ones, indicate SSRIs decrease the function of thrombocytes and fibrin formation via lowered levels of serotonin. Therefore, it has been suggested that temporarily discontinuing SSRIs may benefit patients with bleeding peptic ulcers.

However, sudden cessation of SSRIs can be associated with withdrawal symptoms, which have been reported in up to one-third of such patients.

Dr. Laursen and his associates prospectively analyzed data for 14,343 consecutive patients admitted with bleeding peptic ulcers in Denmark from 2006 to 2014. They investigated associations between SSRI use and several outcomes, adjusted for confounding factors including age, sex, comorbidity, anemia, medication use, circulatory failure at hospital admission, location of ulcer, stigmata of bleeding, and weekend admission.

After adjustment for confounding risk factors, SSRIs were not associated with increased risk of endoscopy-refractory bleeding (odds ratio [OR] 95% confidence interval [CI]: 1.01 [0.78-1.30]), rebleeding (OR [95% CI]: 0.94 [0.81-1.10]), or in-hospital mortality (hazard ratio [95% CI]: 0.84 [0.68-1.05]).

“Patients taking SSRIs have the same outcomes following peptic ulcer bleeding as non-SSRI users. This suggests that there is no clinically significant impairment of hemostatic function,” Dr. Laursen said. “Therefore, it seems safe to continue SSRI treatment in patients developing peptic ulcer bleeding and thereby avoid development of withdrawal symptoms.”

Dr. Laursen noted that the study has several limitations. It’s not a randomized controlled trial, he said, and there’s no information about the types of SSRIs that the patients were taking. Also, there’s a lack of information about possible discontinuation of SSRIs during hospitalization. However, he said, “that doesn’t seem to be a major confounder.”

During the question-and-answer session following his presentation, Dr. Laursen said the increased risk of poor outcome is quite low, but “there may be a small risk that we haven’t found yet. But if it’s small, maybe it doesn’t have an impact in day-to-day practice.”

The research is hospital-funded. Dr. Laursen had no financial disclosures to report.

SAN DIEGO – Taking selective serotonin reuptake inhibitors (SSRIs) was not associated with an increased risk of endoscopy-refractory bleeding, rebleeding, or in-hospital mortality among 14,343 consecutive patients admitted with bleeding peptic ulcer in Denmark.

The study suggests that patients with bleeding peptic ulcers can “continue SSRI treatment if the treatment is well indicated,” and that these patients can otherwise receive treatment similar to that of other patients with peptic ulcer bleeding, Dr. Stig B. Laursen reported at the annual Digestive Disease Week.

Observational research has linked use of SSRI antidepressants to an approximately 1.5-fold increase in upper GI bleeding in peptic ulcer bleeding cases, said Dr. Laursen of Odense (Denmark) University Hospital. Studies, mostly in vitro ones, indicate SSRIs decrease the function of thrombocytes and fibrin formation via lowered levels of serotonin. Therefore, it has been suggested that temporarily discontinuing SSRIs may benefit patients with bleeding peptic ulcers.

However, sudden cessation of SSRIs can be associated with withdrawal symptoms, which have been reported in up to one-third of such patients.

Dr. Laursen and his associates prospectively analyzed data for 14,343 consecutive patients admitted with bleeding peptic ulcers in Denmark from 2006 to 2014. They investigated associations between SSRI use and several outcomes, adjusted for confounding factors including age, sex, comorbidity, anemia, medication use, circulatory failure at hospital admission, location of ulcer, stigmata of bleeding, and weekend admission.

After adjustment for confounding risk factors, SSRIs were not associated with increased risk of endoscopy-refractory bleeding (odds ratio [OR] 95% confidence interval [CI]: 1.01 [0.78-1.30]), rebleeding (OR [95% CI]: 0.94 [0.81-1.10]), or in-hospital mortality (hazard ratio [95% CI]: 0.84 [0.68-1.05]).

“Patients taking SSRIs have the same outcomes following peptic ulcer bleeding as non-SSRI users. This suggests that there is no clinically significant impairment of hemostatic function,” Dr. Laursen said. “Therefore, it seems safe to continue SSRI treatment in patients developing peptic ulcer bleeding and thereby avoid development of withdrawal symptoms.”

Dr. Laursen noted that the study has several limitations. It’s not a randomized controlled trial, he said, and there’s no information about the types of SSRIs that the patients were taking. Also, there’s a lack of information about possible discontinuation of SSRIs during hospitalization. However, he said, “that doesn’t seem to be a major confounder.”

During the question-and-answer session following his presentation, Dr. Laursen said the increased risk of poor outcome is quite low, but “there may be a small risk that we haven’t found yet. But if it’s small, maybe it doesn’t have an impact in day-to-day practice.”

The research is hospital-funded. Dr. Laursen had no financial disclosures to report.

SAN DIEGO – Taking selective serotonin reuptake inhibitors (SSRIs) was not associated with an increased risk of endoscopy-refractory bleeding, rebleeding, or in-hospital mortality among 14,343 consecutive patients admitted with bleeding peptic ulcer in Denmark.

The study suggests that patients with bleeding peptic ulcers can “continue SSRI treatment if the treatment is well indicated,” and that these patients can otherwise receive treatment similar to that of other patients with peptic ulcer bleeding, Dr. Stig B. Laursen reported at the annual Digestive Disease Week.

Observational research has linked use of SSRI antidepressants to an approximately 1.5-fold increase in upper GI bleeding in peptic ulcer bleeding cases, said Dr. Laursen of Odense (Denmark) University Hospital. Studies, mostly in vitro ones, indicate SSRIs decrease the function of thrombocytes and fibrin formation via lowered levels of serotonin. Therefore, it has been suggested that temporarily discontinuing SSRIs may benefit patients with bleeding peptic ulcers.

However, sudden cessation of SSRIs can be associated with withdrawal symptoms, which have been reported in up to one-third of such patients.

Dr. Laursen and his associates prospectively analyzed data for 14,343 consecutive patients admitted with bleeding peptic ulcers in Denmark from 2006 to 2014. They investigated associations between SSRI use and several outcomes, adjusted for confounding factors including age, sex, comorbidity, anemia, medication use, circulatory failure at hospital admission, location of ulcer, stigmata of bleeding, and weekend admission.

After adjustment for confounding risk factors, SSRIs were not associated with increased risk of endoscopy-refractory bleeding (odds ratio [OR] 95% confidence interval [CI]: 1.01 [0.78-1.30]), rebleeding (OR [95% CI]: 0.94 [0.81-1.10]), or in-hospital mortality (hazard ratio [95% CI]: 0.84 [0.68-1.05]).

“Patients taking SSRIs have the same outcomes following peptic ulcer bleeding as non-SSRI users. This suggests that there is no clinically significant impairment of hemostatic function,” Dr. Laursen said. “Therefore, it seems safe to continue SSRI treatment in patients developing peptic ulcer bleeding and thereby avoid development of withdrawal symptoms.”

Dr. Laursen noted that the study has several limitations. It’s not a randomized controlled trial, he said, and there’s no information about the types of SSRIs that the patients were taking. Also, there’s a lack of information about possible discontinuation of SSRIs during hospitalization. However, he said, “that doesn’t seem to be a major confounder.”

During the question-and-answer session following his presentation, Dr. Laursen said the increased risk of poor outcome is quite low, but “there may be a small risk that we haven’t found yet. But if it’s small, maybe it doesn’t have an impact in day-to-day practice.”

The research is hospital-funded. Dr. Laursen had no financial disclosures to report.

SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.

For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.

Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.

To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).

The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.

Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.

The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).

Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.

Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.

SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.

For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.

Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.

To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).

The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.

Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.

The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).

Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.

Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.

SAN DIEGO – Patients who have persistent leukocytosis (greater than 12 x 109 white blood cells per liter) or persistent systemic inflammatory response syndrome (SIRS) on the day of scheduled cholecystectomy may have unrecognized pancreatic necrosis, which increases the risk of postsurgical organ failure and infected necrosis, Dr. Wilson Kwong reported.

For these patients, “we recommend performing a contrast-enhanced CT scan on day 4 or 5 to reassess for necrosis,” Dr. Kwong of the gastroenterology department at the University California, San Diego, said in an interview. “Patients who have necrosis should undergo interval cholecystectomy instead, while those without necrosis are likely safe to proceed with laparoscopic cholecystectomy,” he added.

Guidelines recommend same-admission cholecystectomy for mild acute gallstone pancreatitis, although this approach will send some patients with unrecognized necrotizing pancreatitis to surgery, “with unknown consequences,” Dr. Kwong said at the annual Digestive Diseases Week.

To better understand presurgical predictors of necrotizing pancreatitis, Dr. Kwong and his coauthor, Dr. Santhi Swaroop Vege of the Mayo Clinic, Rochester, Minn., studied 46 Mayo Clinic patients with apparent mild acute gallstone pancreatitis who in fact had necrotizing pancreatitis diagnosed during same-admission laparoscopic cholecystectomies (SALCs).

The most frequent characteristics of patients with unrecognized necrotizing pancreatitis included persistent SIRS (area under the curve, 0.96) and persistent leukocytosis (AUC, 0.92) on the day of cholecystectomy (both P less than .0001). However, 82% of patients with unrecognized necrotizing pancreatitis met criteria for SIRS by their second day in the hospital, with SIRS continuing until the day of planned cholecystectomy.

Next, the investigators compared the SALC patients with 48 patients who had necrotizing pancreatitis, but did not undergo SALC. In all, 24% of SALC patients developed new organ failure, compared with none of the comparison group (P = .0003). The SALC patients also had nearly double the rate of culture-confirmed infected necrosis (52% vs. 27%, P = .02), and stayed about 1.5 days longer in the hospital (26 vs. 24.5 days, P = .049). The chances of undergoing an intervention for necrotizing pancreatitis, conversion to open cholecystectomy, or death were slightly higher for SALC patients, compared with controls, but none of these differences reached statistical significance. Two SALC patients (4%) died, compared with 2% of patients who did not undergo SALC, the investigators reported.

The researchers also compared the SALC patients with a second control group of 48 patients who were later confirmed during SALC to have true mild acute gallstone pancreatitis. Fully 91% of patients with necrotizing pancreatitis met criteria for SIRS on the day of surgery, compared with none of the patients with acute gallstone pancreatitis (P less than .0001). Furthermore, all 11 patients with necrotizing pancreatitis and available test results had persistent leukocytosis on the day of surgery, compared with only 21% of the gallstone pancreatitis group (P less than .0001).

Finally, the researchers looked at the magnitude of the problem of unrecognized necrotizing pancreatitis. “From January 2014 to August 2015, 102 consecutive patients were directly admitted to Mayo Clinic, Rochester, with acute gallstone pancreatitis and underwent SALC,” they reported. “After laparoscopic cholecystectomy, seven of these patients were discovered to have previously unrecognized necrotizing pancreatitis, thus giving a 7% occurrence rate for this complication during this recent time period.” Accurately identifying patients with emerging necrotizing pancreatitis is crucial to help prevent potentially severe complications after SALC, they emphasized.

Dr. Kwong had no relevant financial disclosures. Dr. Vege disclosed consulting fees and other compensation from Takeda and several other companies.

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

Amy Karon

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

Amy Karon

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

SAN DIEGO – A disposable Endocuff cut colonoscopic withdrawal times by nearly a minute and slightly improved polyp detection, compared with standard colonoscopy, according to a randomized, prospective trial of 562 patients.

The Endocuff caused no known adverse effects except for superficial mucosal trauma, Dr. Paul Feuerstadt said at the annual Digestive Disease Week. The study, which is the first of its kind in the United States, suggests that the Endocuff can improve the efficiency of colonoscopies without undermining detection rates, he added.

The plastic, flexible Endocuff slides onto the tip of a standard colonoscope, and has phalanges that press on the colonic mucosa “to improve polyp and adenoma detection rates, at least in theory,” said Dr. Feuerstadt, who is at the Gastroenterology Center of Connecticut in Hamden, Conn.

Use of the device improved the polyp detection rate by 63% and adenoma detection by 86% in a previous study in Germany.

Amy Karon

For the current study, Dr. Feuerstadt and his associates screened 1,067 consecutive patients at two endoscopy centers in Connecticut, and excluded those with colitis, inflammatory bowel disease, diarrhea, chronic splenomegaly, and a history of surgical resection or colonic stricture. The 562 remaining patients were randomized to either Endocuff-assisted or standard colonoscopies performed by eight endoscopists with historically high adenoma detection rates of nearly 44%.

Use of the Endocuff seemed to slightly improve polyp detection, though none of the primary comparisons reached statistical significance, despite sufficient study power, Dr. Feuerstadt said. The rate of polyp detection was 63% for Endocuff-assisted colonoscopy and 60% for standard colonoscopy (P = .41), while rates of adenoma detection were 42% and 45%, respectively. There was a nonsignificant trend toward higher detection of sessile serrated adenomas (11% versus 9%; P = .37).

Notably, average withdrawal times were 9.9 minutes with the Endocuff (standard deviation, 5.5 minutes), versus 11.1 minutes without it (standard deviation, 5.9 minutes; P = .02). There were no perforations or other major adverse events, no instances of the Endocuff coming off the scope, and no difference in bleeding rates between the two groups.

However, 8% of Endocuff patients had mild mucosal trauma, compared with none of the control group, Dr. Feuerstadt reported.

The two groups resembled one another demographically, clinically, and in terms of their family history of colonic polyps. However, the Endocuff group had a higher frequency of first-degree relatives younger than age 50 years with colon cancer, Dr. Feuerstadt noted.

The endoscopists had an average historical ADR of 43.6%, “very similar to the 44.7% we saw in the study,” he added. “The device yields similar adenoma detection rates overall, with shorter withdrawal times, thereby increasing colonoscopic efficiency.”

Dr. Feuerstadt did not report funding sources. He disclosed consulting fees from Medivators, which makes endoscope reprocessing and related products.

Among a large cohort of patients referred for endoscopy for suspected celiac disease as well as all upper gastrointestinal symptoms, a single additional D1 biopsy specimen from any site significantly increased the diagnostic yield for celiac disease, according to researchers.

Of 1,378 patients who had D2 and D1 biopsy specimens taken, 268 were newly diagnosed with celiac disease, and 26 had villous atrophy confined to D1, defined as ultrashort celiac disease (USCD). Compared with a standard D2 biopsy, an additional D1 biopsy increased the diagnostic yield by 9.7% (P less than .0001). Among the 26 diagnosed with USCD, 7 had normal D2 biopsy specimens, and 4 others had negative tests for endomysial antibodies (EMAs), totaling 11 patients for whom celiac disease would have been missed in the absence of a D1 biopsy.

“The addition of a D1 biopsy specimen to diagnose celiac disease may reduce the known delay in diagnosis that many patients with celiac disease experience. This may allow earlier institution of a gluten-free diet, potentially prevent nutritional deficiencies, and reduce the symptomatic burden of celiac disease,” wrote Dr. Peter Mooney of Royal Hallamshire Hospital, Sheffield, England, and his colleagues. (Gastroenterology 2016 April 7. doi: 10.1053/j-gastro.2016.01.029).

The prospective study recruited 1,378 consecutive patients referred to a single teaching hospital for endoscopy from 2008 to 2014. In total, 268 were newly diagnosed with celiac disease, and 26 were diagnosed with USCD.

To investigate the optimal site for targeted D1 sampling, 171 patients underwent quadrantic D1 biopsy, 61 of whom were diagnosed with celiac disease. Biopsy specimens from any topographical area resulted in high sensitivity, a fact that increases the feasibility of a D1 biopsy policy, since no specific target area is required, according to the researchers. Nonceliac abnormalities such as peptic duodenitis or gastric heterotopia have been suggested to impede interpretation of D1 biopsies, but these were rare in the study and did not interfere with the analysis.

USCD may be an early form of conventional celiac disease, an idea supported by the findings. Compared with patients diagnosed with conventional celiac disease, patients diagnosed with USCD were younger and had a much lower rate of diarrhea, which by decision-tree analysis was the single factor discriminating between the two groups. Compared with healthy controls, individuals with conventional celiac disease, but not USCD, were more likely to present with anemia, diarrhea, a family history of celiac disease, lethargy, and osteoporosis. Patients with USCD and conventional disease had similar rates of IgA tissue transglutaminase antibodies (tTG), but USCD patients had lower titers (P less than .001). The USCD group also had fewer ferritin and folate deficiencies.

The researchers suggested that clinical phenotypic differences may be due to minimal loss of absorptive capacity associated with a short segment of villous atrophy. Given the younger average age at diagnosis of USCD and lower tTG titers, USCD may represent an early stage of celiac disease, resulting in fewer nutritional deficiencies observed because of a shorter lead time to diagnosis.

Although USCD patients had a milder clinical phenotype, which has raised concerns that a strict gluten-free diet may be unnecessary, follow-up data demonstrated that a gluten-free diet produced improvement in symptoms and a significant decrease in the tTG titer. These results may indicate that the immune cascade was switched off, according to the researchers, and that early diagnosis may present a unique opportunity to prevent further micronutrient deficiency.

Dr. Mooney and his coauthors reported having no relevant financial disclosures.

Among a large cohort of patients referred for endoscopy for suspected celiac disease as well as all upper gastrointestinal symptoms, a single additional D1 biopsy specimen from any site significantly increased the diagnostic yield for celiac disease, according to researchers.

Of 1,378 patients who had D2 and D1 biopsy specimens taken, 268 were newly diagnosed with celiac disease, and 26 had villous atrophy confined to D1, defined as ultrashort celiac disease (USCD). Compared with a standard D2 biopsy, an additional D1 biopsy increased the diagnostic yield by 9.7% (P less than .0001). Among the 26 diagnosed with USCD, 7 had normal D2 biopsy specimens, and 4 others had negative tests for endomysial antibodies (EMAs), totaling 11 patients for whom celiac disease would have been missed in the absence of a D1 biopsy.

“The addition of a D1 biopsy specimen to diagnose celiac disease may reduce the known delay in diagnosis that many patients with celiac disease experience. This may allow earlier institution of a gluten-free diet, potentially prevent nutritional deficiencies, and reduce the symptomatic burden of celiac disease,” wrote Dr. Peter Mooney of Royal Hallamshire Hospital, Sheffield, England, and his colleagues. (Gastroenterology 2016 April 7. doi: 10.1053/j-gastro.2016.01.029).

The prospective study recruited 1,378 consecutive patients referred to a single teaching hospital for endoscopy from 2008 to 2014. In total, 268 were newly diagnosed with celiac disease, and 26 were diagnosed with USCD.

To investigate the optimal site for targeted D1 sampling, 171 patients underwent quadrantic D1 biopsy, 61 of whom were diagnosed with celiac disease. Biopsy specimens from any topographical area resulted in high sensitivity, a fact that increases the feasibility of a D1 biopsy policy, since no specific target area is required, according to the researchers. Nonceliac abnormalities such as peptic duodenitis or gastric heterotopia have been suggested to impede interpretation of D1 biopsies, but these were rare in the study and did not interfere with the analysis.

USCD may be an early form of conventional celiac disease, an idea supported by the findings. Compared with patients diagnosed with conventional celiac disease, patients diagnosed with USCD were younger and had a much lower rate of diarrhea, which by decision-tree analysis was the single factor discriminating between the two groups. Compared with healthy controls, individuals with conventional celiac disease, but not USCD, were more likely to present with anemia, diarrhea, a family history of celiac disease, lethargy, and osteoporosis. Patients with USCD and conventional disease had similar rates of IgA tissue transglutaminase antibodies (tTG), but USCD patients had lower titers (P less than .001). The USCD group also had fewer ferritin and folate deficiencies.

The researchers suggested that clinical phenotypic differences may be due to minimal loss of absorptive capacity associated with a short segment of villous atrophy. Given the younger average age at diagnosis of USCD and lower tTG titers, USCD may represent an early stage of celiac disease, resulting in fewer nutritional deficiencies observed because of a shorter lead time to diagnosis.

Although USCD patients had a milder clinical phenotype, which has raised concerns that a strict gluten-free diet may be unnecessary, follow-up data demonstrated that a gluten-free diet produced improvement in symptoms and a significant decrease in the tTG titer. These results may indicate that the immune cascade was switched off, according to the researchers, and that early diagnosis may present a unique opportunity to prevent further micronutrient deficiency.

Dr. Mooney and his coauthors reported having no relevant financial disclosures.

Among a large cohort of patients referred for endoscopy for suspected celiac disease as well as all upper gastrointestinal symptoms, a single additional D1 biopsy specimen from any site significantly increased the diagnostic yield for celiac disease, according to researchers.

Of 1,378 patients who had D2 and D1 biopsy specimens taken, 268 were newly diagnosed with celiac disease, and 26 had villous atrophy confined to D1, defined as ultrashort celiac disease (USCD). Compared with a standard D2 biopsy, an additional D1 biopsy increased the diagnostic yield by 9.7% (P less than .0001). Among the 26 diagnosed with USCD, 7 had normal D2 biopsy specimens, and 4 others had negative tests for endomysial antibodies (EMAs), totaling 11 patients for whom celiac disease would have been missed in the absence of a D1 biopsy.

“The addition of a D1 biopsy specimen to diagnose celiac disease may reduce the known delay in diagnosis that many patients with celiac disease experience. This may allow earlier institution of a gluten-free diet, potentially prevent nutritional deficiencies, and reduce the symptomatic burden of celiac disease,” wrote Dr. Peter Mooney of Royal Hallamshire Hospital, Sheffield, England, and his colleagues. (Gastroenterology 2016 April 7. doi: 10.1053/j-gastro.2016.01.029).

The prospective study recruited 1,378 consecutive patients referred to a single teaching hospital for endoscopy from 2008 to 2014. In total, 268 were newly diagnosed with celiac disease, and 26 were diagnosed with USCD.

To investigate the optimal site for targeted D1 sampling, 171 patients underwent quadrantic D1 biopsy, 61 of whom were diagnosed with celiac disease. Biopsy specimens from any topographical area resulted in high sensitivity, a fact that increases the feasibility of a D1 biopsy policy, since no specific target area is required, according to the researchers. Nonceliac abnormalities such as peptic duodenitis or gastric heterotopia have been suggested to impede interpretation of D1 biopsies, but these were rare in the study and did not interfere with the analysis.

USCD may be an early form of conventional celiac disease, an idea supported by the findings. Compared with patients diagnosed with conventional celiac disease, patients diagnosed with USCD were younger and had a much lower rate of diarrhea, which by decision-tree analysis was the single factor discriminating between the two groups. Compared with healthy controls, individuals with conventional celiac disease, but not USCD, were more likely to present with anemia, diarrhea, a family history of celiac disease, lethargy, and osteoporosis. Patients with USCD and conventional disease had similar rates of IgA tissue transglutaminase antibodies (tTG), but USCD patients had lower titers (P less than .001). The USCD group also had fewer ferritin and folate deficiencies.

The researchers suggested that clinical phenotypic differences may be due to minimal loss of absorptive capacity associated with a short segment of villous atrophy. Given the younger average age at diagnosis of USCD and lower tTG titers, USCD may represent an early stage of celiac disease, resulting in fewer nutritional deficiencies observed because of a shorter lead time to diagnosis.

Although USCD patients had a milder clinical phenotype, which has raised concerns that a strict gluten-free diet may be unnecessary, follow-up data demonstrated that a gluten-free diet produced improvement in symptoms and a significant decrease in the tTG titer. These results may indicate that the immune cascade was switched off, according to the researchers, and that early diagnosis may present a unique opportunity to prevent further micronutrient deficiency.

Dr. Mooney and his coauthors reported having no relevant financial disclosures.

Surveillance of CDNK2A mutation carriers detected most pancreatic ductal carcinoma in situ (PDAC) at a resectable stage, while the surveillance benefit was lower for those with familial prostate cancer.

Among 178 CDKN2A mutation carriers, PDAC was detected in 13 (7.3%), 9 of whom underwent surgery. Compared with previously reported rates of 15%-20% for symptomatic PDAC, this 70% resection rate represents a substantial increase. The 5-year survival rate of 24% for screen-detected PDAC was higher than 4%-7% reported for symptomatic sporadic PDAC. Among individuals with familial prostate cancer (FPC), 13 of 214 individuals (6.1%) underwent surgery, but with a higher proportion of precursor lesions detected, just four high-risk lesions (1.9% of screened FPC patients) were removed.

Whether surveillance improved prognosis for FPC families was difficult to determine, according to the investigators. The yield of PDAC was low at 0.9%, as was the yield of relevant precursor lesions (grade 3 PanIN and high-grade IPMN) at 1.9%.

“However, if surgical removal of multifocal grade 2 PanIN and multifocal BD-IPMNs is regarded as beneficial, the diagnostic yield increases to 3.7% (eight of 214 patients), and surveillance of FPC might also be considered effective,” wrote Dr. Hans Vasen, professor in the department of gastroenterology and hepatology at the Leiden University Medical Center, the Netherlands, and colleagues. “The value of surveillance of FPC is still not clear, and the main effect seems to be prevention of PDAC by removal of” precursor lesions, they added (J Clin Oncol. 2016 Apr 25. doi: 10.1200/JCO.2015.64.0730).

The retrospective evaluation of an ongoing prospective follow-up study included 411 high-risk individuals: 178 with CDKN2A mutations, 214 with familial pancreatic cancer, and 19 with BRCA1/2 or PALB2 mutations. The study was conducted at three expert centers in Marburg, Germany; Leiden, the Netherlands; and Madrid.

In the BRCA1/2 and PALB2 mutation cohort, one individual (3.8%) with a BRCA2 mutation developed PDAC and underwent surgery; 17 months after the surgery this patient died of liver metastasis. Two others underwent surgery for cystic lesions and are in good health at 10 and 21 months after surgery.

In the cohort of CDKN2A mutation carriers, the mean age at the start of surveillance was 56 years (range, 37-75) and the mean follow-up time was 53 months (range, 0-169): in total, 866 MRIs and 106 endoscopic ultrasounds were conducted. In the FPC group, the mean age was 48 years (range, 27-81), and the mean follow up was 2.8 years (range, 0-10.8): 618 MRIs and 402 endoscopic ultrasounds were conducted. Among BRCA1/2 and PALB2 mutation carriers, the mean age was 52.6 years (range, 25-70), and the mean follow up was 32.7 months (range, 1-119).

Surveillance of CDNK2A mutation carriers detected most pancreatic ductal carcinoma in situ (PDAC) at a resectable stage, while the surveillance benefit was lower for those with familial prostate cancer.

Among 178 CDKN2A mutation carriers, PDAC was detected in 13 (7.3%), 9 of whom underwent surgery. Compared with previously reported rates of 15%-20% for symptomatic PDAC, this 70% resection rate represents a substantial increase. The 5-year survival rate of 24% for screen-detected PDAC was higher than 4%-7% reported for symptomatic sporadic PDAC. Among individuals with familial prostate cancer (FPC), 13 of 214 individuals (6.1%) underwent surgery, but with a higher proportion of precursor lesions detected, just four high-risk lesions (1.9% of screened FPC patients) were removed.

Whether surveillance improved prognosis for FPC families was difficult to determine, according to the investigators. The yield of PDAC was low at 0.9%, as was the yield of relevant precursor lesions (grade 3 PanIN and high-grade IPMN) at 1.9%.

“However, if surgical removal of multifocal grade 2 PanIN and multifocal BD-IPMNs is regarded as beneficial, the diagnostic yield increases to 3.7% (eight of 214 patients), and surveillance of FPC might also be considered effective,” wrote Dr. Hans Vasen, professor in the department of gastroenterology and hepatology at the Leiden University Medical Center, the Netherlands, and colleagues. “The value of surveillance of FPC is still not clear, and the main effect seems to be prevention of PDAC by removal of” precursor lesions, they added (J Clin Oncol. 2016 Apr 25. doi: 10.1200/JCO.2015.64.0730).

The retrospective evaluation of an ongoing prospective follow-up study included 411 high-risk individuals: 178 with CDKN2A mutations, 214 with familial pancreatic cancer, and 19 with BRCA1/2 or PALB2 mutations. The study was conducted at three expert centers in Marburg, Germany; Leiden, the Netherlands; and Madrid.

In the BRCA1/2 and PALB2 mutation cohort, one individual (3.8%) with a BRCA2 mutation developed PDAC and underwent surgery; 17 months after the surgery this patient died of liver metastasis. Two others underwent surgery for cystic lesions and are in good health at 10 and 21 months after surgery.

In the cohort of CDKN2A mutation carriers, the mean age at the start of surveillance was 56 years (range, 37-75) and the mean follow-up time was 53 months (range, 0-169): in total, 866 MRIs and 106 endoscopic ultrasounds were conducted. In the FPC group, the mean age was 48 years (range, 27-81), and the mean follow up was 2.8 years (range, 0-10.8): 618 MRIs and 402 endoscopic ultrasounds were conducted. Among BRCA1/2 and PALB2 mutation carriers, the mean age was 52.6 years (range, 25-70), and the mean follow up was 32.7 months (range, 1-119).

Surveillance of CDNK2A mutation carriers detected most pancreatic ductal carcinoma in situ (PDAC) at a resectable stage, while the surveillance benefit was lower for those with familial prostate cancer.

Among 178 CDKN2A mutation carriers, PDAC was detected in 13 (7.3%), 9 of whom underwent surgery. Compared with previously reported rates of 15%-20% for symptomatic PDAC, this 70% resection rate represents a substantial increase. The 5-year survival rate of 24% for screen-detected PDAC was higher than 4%-7% reported for symptomatic sporadic PDAC. Among individuals with familial prostate cancer (FPC), 13 of 214 individuals (6.1%) underwent surgery, but with a higher proportion of precursor lesions detected, just four high-risk lesions (1.9% of screened FPC patients) were removed.

Whether surveillance improved prognosis for FPC families was difficult to determine, according to the investigators. The yield of PDAC was low at 0.9%, as was the yield of relevant precursor lesions (grade 3 PanIN and high-grade IPMN) at 1.9%.

“However, if surgical removal of multifocal grade 2 PanIN and multifocal BD-IPMNs is regarded as beneficial, the diagnostic yield increases to 3.7% (eight of 214 patients), and surveillance of FPC might also be considered effective,” wrote Dr. Hans Vasen, professor in the department of gastroenterology and hepatology at the Leiden University Medical Center, the Netherlands, and colleagues. “The value of surveillance of FPC is still not clear, and the main effect seems to be prevention of PDAC by removal of” precursor lesions, they added (J Clin Oncol. 2016 Apr 25. doi: 10.1200/JCO.2015.64.0730).

The retrospective evaluation of an ongoing prospective follow-up study included 411 high-risk individuals: 178 with CDKN2A mutations, 214 with familial pancreatic cancer, and 19 with BRCA1/2 or PALB2 mutations. The study was conducted at three expert centers in Marburg, Germany; Leiden, the Netherlands; and Madrid.

In the BRCA1/2 and PALB2 mutation cohort, one individual (3.8%) with a BRCA2 mutation developed PDAC and underwent surgery; 17 months after the surgery this patient died of liver metastasis. Two others underwent surgery for cystic lesions and are in good health at 10 and 21 months after surgery.

In the cohort of CDKN2A mutation carriers, the mean age at the start of surveillance was 56 years (range, 37-75) and the mean follow-up time was 53 months (range, 0-169): in total, 866 MRIs and 106 endoscopic ultrasounds were conducted. In the FPC group, the mean age was 48 years (range, 27-81), and the mean follow up was 2.8 years (range, 0-10.8): 618 MRIs and 402 endoscopic ultrasounds were conducted. Among BRCA1/2 and PALB2 mutation carriers, the mean age was 52.6 years (range, 25-70), and the mean follow up was 32.7 months (range, 1-119).

Patients who receive rectal indomethacin after undergoing endoscopic retrograde cholangiopancreatography (ERCP) are not any less likely to develop pancreatitis than individuals who don’t, according to the findings of a recent study published in Gastroenterology (2016 Jan 9. doi: 10.1053/j.gastro.2015.12.018).

“These results are in contrast to recent studies highlighting the benefit of rectal NSAIDS to prevent PEP [post-ECRP pancreatitis] in high-risk patients [and] counter the guidelines espoused by the European Society for Gastrointestinal Endoscopy, which recently recommended giving rectal indomethacin to prevent PEP in all patients undergoing ERCP,” said the study authors, led by Dr. John M. Levenick of Penn State University in Hershey, Pa.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Dr. Levenick and his coinvestigators screened 604 consecutive patients undergoing ERCP, with and without endoscopic ultrasound, at the Dartmouth-Hitchcock Medical Center between March 2013 and December 2014, eventually enrolling and randomizing 449 subjects into two cohorts: one in which subjects were given indomethacin after undergoing ERCP (n = 223), and one in which subjects were simply given a placebo (n = 226). Randomization happened after subjects’ major papilla had been reached, and cannulation attempts were started.

Individuals were excluded if they had active acute pancreatitis or had undergone ERCP to treat or diagnose acute pancreatitis, if they had any contraindications or allergies to NSAIDs, or were younger than 18 years of age, among other factors. The mean age of the indomethacin cohort was 64.9 years, with 118 (52.9%) females; in the placebo cohort, mean age was 64.3 years and 118 (52.2%) were female.

Pancreatitis occurred in 27 subjects overall, 16 (7.2%) of whom were in the indomethacin cohort and the other 11 (4.9%) were on placebo followed ERCP (P = .33). No subjects receiving indomethacin had severe or moderately severe PEP, but one subject had severe PEP and one had moderately severe PEP in the placebo cohort (P = 1.0). There was no necrotizing pancreatitis in either cohort, nor were there any significant differences in gastrointestinal bleeding (P = .75), death (P = .25), or 30-day hospital readmission (P = .1) between the two cohorts.

“Prophylactic rectal indomethacin did not reduce the incidence or severity of PEP in consecutive patients undergoing ERCP,” Dr. Levenick and his coauthors concluded, adding that “guidelines that recommend the administration of rectal indomethacin in all patients undergoing ERCP should be reconsidered.”

This study was funded by the National Pancreas Foundation and a grant from the National Institutes of Health. Dr. Levenick and his coauthors did not report any financial disclosures.

[email protected]

Patients who receive rectal indomethacin after undergoing endoscopic retrograde cholangiopancreatography (ERCP) are not any less likely to develop pancreatitis than individuals who don’t, according to the findings of a recent study published in Gastroenterology (2016 Jan 9. doi: 10.1053/j.gastro.2015.12.018).

“These results are in contrast to recent studies highlighting the benefit of rectal NSAIDS to prevent PEP [post-ECRP pancreatitis] in high-risk patients [and] counter the guidelines espoused by the European Society for Gastrointestinal Endoscopy, which recently recommended giving rectal indomethacin to prevent PEP in all patients undergoing ERCP,” said the study authors, led by Dr. John M. Levenick of Penn State University in Hershey, Pa.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Dr. Levenick and his coinvestigators screened 604 consecutive patients undergoing ERCP, with and without endoscopic ultrasound, at the Dartmouth-Hitchcock Medical Center between March 2013 and December 2014, eventually enrolling and randomizing 449 subjects into two cohorts: one in which subjects were given indomethacin after undergoing ERCP (n = 223), and one in which subjects were simply given a placebo (n = 226). Randomization happened after subjects’ major papilla had been reached, and cannulation attempts were started.

Individuals were excluded if they had active acute pancreatitis or had undergone ERCP to treat or diagnose acute pancreatitis, if they had any contraindications or allergies to NSAIDs, or were younger than 18 years of age, among other factors. The mean age of the indomethacin cohort was 64.9 years, with 118 (52.9%) females; in the placebo cohort, mean age was 64.3 years and 118 (52.2%) were female.

Pancreatitis occurred in 27 subjects overall, 16 (7.2%) of whom were in the indomethacin cohort and the other 11 (4.9%) were on placebo followed ERCP (P = .33). No subjects receiving indomethacin had severe or moderately severe PEP, but one subject had severe PEP and one had moderately severe PEP in the placebo cohort (P = 1.0). There was no necrotizing pancreatitis in either cohort, nor were there any significant differences in gastrointestinal bleeding (P = .75), death (P = .25), or 30-day hospital readmission (P = .1) between the two cohorts.

“Prophylactic rectal indomethacin did not reduce the incidence or severity of PEP in consecutive patients undergoing ERCP,” Dr. Levenick and his coauthors concluded, adding that “guidelines that recommend the administration of rectal indomethacin in all patients undergoing ERCP should be reconsidered.”

This study was funded by the National Pancreas Foundation and a grant from the National Institutes of Health. Dr. Levenick and his coauthors did not report any financial disclosures.

[email protected]

Patients who receive rectal indomethacin after undergoing endoscopic retrograde cholangiopancreatography (ERCP) are not any less likely to develop pancreatitis than individuals who don’t, according to the findings of a recent study published in Gastroenterology (2016 Jan 9. doi: 10.1053/j.gastro.2015.12.018).

“These results are in contrast to recent studies highlighting the benefit of rectal NSAIDS to prevent PEP [post-ECRP pancreatitis] in high-risk patients [and] counter the guidelines espoused by the European Society for Gastrointestinal Endoscopy, which recently recommended giving rectal indomethacin to prevent PEP in all patients undergoing ERCP,” said the study authors, led by Dr. John M. Levenick of Penn State University in Hershey, Pa.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Dr. Levenick and his coinvestigators screened 604 consecutive patients undergoing ERCP, with and without endoscopic ultrasound, at the Dartmouth-Hitchcock Medical Center between March 2013 and December 2014, eventually enrolling and randomizing 449 subjects into two cohorts: one in which subjects were given indomethacin after undergoing ERCP (n = 223), and one in which subjects were simply given a placebo (n = 226). Randomization happened after subjects’ major papilla had been reached, and cannulation attempts were started.

Individuals were excluded if they had active acute pancreatitis or had undergone ERCP to treat or diagnose acute pancreatitis, if they had any contraindications or allergies to NSAIDs, or were younger than 18 years of age, among other factors. The mean age of the indomethacin cohort was 64.9 years, with 118 (52.9%) females; in the placebo cohort, mean age was 64.3 years and 118 (52.2%) were female.

Pancreatitis occurred in 27 subjects overall, 16 (7.2%) of whom were in the indomethacin cohort and the other 11 (4.9%) were on placebo followed ERCP (P = .33). No subjects receiving indomethacin had severe or moderately severe PEP, but one subject had severe PEP and one had moderately severe PEP in the placebo cohort (P = 1.0). There was no necrotizing pancreatitis in either cohort, nor were there any significant differences in gastrointestinal bleeding (P = .75), death (P = .25), or 30-day hospital readmission (P = .1) between the two cohorts.

“Prophylactic rectal indomethacin did not reduce the incidence or severity of PEP in consecutive patients undergoing ERCP,” Dr. Levenick and his coauthors concluded, adding that “guidelines that recommend the administration of rectal indomethacin in all patients undergoing ERCP should be reconsidered.”

This study was funded by the National Pancreas Foundation and a grant from the National Institutes of Health. Dr. Levenick and his coauthors did not report any financial disclosures.

[email protected]

As magnetic resonance imaging technology continues to advance year after year, so does MRI’s ability to accurately detect pancreatic cysts, according to a new study published in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2015.08.038).

“To our knowledge, this is the first study to analyze the relationship between the technical improvements in imaging techniques (specifically, MRI) and the presence of incidentally found PCLs [pancreatic cystic lesions],” said the study authors, led by Dr. Michael B. Wallace of the Mayo Clinic in Jacksonville, Fla.

Dr. Wallace and his coinvestigators launched this retrospective descriptive study selecting the first 50 consecutive abdominal MRI patients at the Jacksonville Mayo Clinic during January and February of each year from 2005 through 2014, for a total of 500 cases who met inclusion criteria included in the study. Patients were excluded if they had preexisting symptomatic or asymptomatic pancreatitis, either acute or chronic, pancreatic masses, pancreatic cysts, pancreatic surgery, pancreatic symptoms, or any pancreas-related indications found by MRI.

The clinic underwent periodic MRI updates over the course of the 10-year study, along with requisite software updates to “take advantage of the new hardware technology,” the study explains. Major hardware improvements, provided by Siemens Medical Solutions USA, were Symphony/Sonata, Espree/Avanto, and Aera/Skyra, while software updates corresponding to each hardware update were VA, VB, and VD, respectively.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Furthermore, each software update had other, smaller upgrades, leading to a total of 20 combinations of MRI hardware and software on which MRIs were performed over the 10 years. Every MRI taken included “an axial and a coronal T2-weighted single-shot (HASTE) pulse sequence [with] TR 1400-1500 ms, TE 82-99 ms, and slice thickness 5-7 mm (gap, 0.5-0.7 mm).” Each MRI was analyzed by a pancreatic MRI specialist to find incidental cysts.

The number of patients found with pancreatic cysts increased incrementally from 2005 to 2014, with 2010 being the year with the highest number. A total of 208 subjects (41.6%) were found to have incidental cysts, but only 44 of these cases were discovered in the original MRI. The presence of cysts was associated with older age in patients who had them; only 20% of all subjects under 50 years of age had cysts, compared to 32.4% of those between 50 and 60 years, 54.9% of those between 60 and 70 years, and 61.5% of those over the age of 70 years (P less than .01).

Additionally, 56.4% of all subjects with diabetes (P less than .01), 59.0% of subjects with nonmelanoma skin cancer (P less than .03), and 58.1% of those with hepatocarcinoma (P less than .02) were also found to have cysts. Most striking, however, is that newer hardware and software permutations were able to detect cysts in 56.3% (Skyra) of patients who had them, compared with only 30.3% (Symphony) of patients who underwent MRI on older technology.

“The variable field strength” (1.5 T vs. 3 T) was not significantly related to the presence of PCLs,” Dr. Wallace and his coauthors concluded. “We believe this may be secondary to the lack of power of the analysis, because only 6% of the examinations were 3-T studies. Therefore, we speculate that this relationship may be confirmed if the number of 3-T studies increased.”

Males and females each made up roughly 50% of the study population, with a median age of 60 years and 85% being white. Additionally, 4% of subjects had a family history of pancreatic cancer, 12% had a personal history of solid organ transplant, and 53% had a personal history of smoking.

This study was funded by the Mayo Clinic. Dr. Wallace disclosed that he has received grant funding from Olympus, Boston Scientific, and Cosmo Pharmaceuticals, and travel support from Olympus. No other authors reported any financial disclosures.

[email protected]

As magnetic resonance imaging technology continues to advance year after year, so does MRI’s ability to accurately detect pancreatic cysts, according to a new study published in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2015.08.038).

“To our knowledge, this is the first study to analyze the relationship between the technical improvements in imaging techniques (specifically, MRI) and the presence of incidentally found PCLs [pancreatic cystic lesions],” said the study authors, led by Dr. Michael B. Wallace of the Mayo Clinic in Jacksonville, Fla.

Dr. Wallace and his coinvestigators launched this retrospective descriptive study selecting the first 50 consecutive abdominal MRI patients at the Jacksonville Mayo Clinic during January and February of each year from 2005 through 2014, for a total of 500 cases who met inclusion criteria included in the study. Patients were excluded if they had preexisting symptomatic or asymptomatic pancreatitis, either acute or chronic, pancreatic masses, pancreatic cysts, pancreatic surgery, pancreatic symptoms, or any pancreas-related indications found by MRI.

The clinic underwent periodic MRI updates over the course of the 10-year study, along with requisite software updates to “take advantage of the new hardware technology,” the study explains. Major hardware improvements, provided by Siemens Medical Solutions USA, were Symphony/Sonata, Espree/Avanto, and Aera/Skyra, while software updates corresponding to each hardware update were VA, VB, and VD, respectively.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Furthermore, each software update had other, smaller upgrades, leading to a total of 20 combinations of MRI hardware and software on which MRIs were performed over the 10 years. Every MRI taken included “an axial and a coronal T2-weighted single-shot (HASTE) pulse sequence [with] TR 1400-1500 ms, TE 82-99 ms, and slice thickness 5-7 mm (gap, 0.5-0.7 mm).” Each MRI was analyzed by a pancreatic MRI specialist to find incidental cysts.

The number of patients found with pancreatic cysts increased incrementally from 2005 to 2014, with 2010 being the year with the highest number. A total of 208 subjects (41.6%) were found to have incidental cysts, but only 44 of these cases were discovered in the original MRI. The presence of cysts was associated with older age in patients who had them; only 20% of all subjects under 50 years of age had cysts, compared to 32.4% of those between 50 and 60 years, 54.9% of those between 60 and 70 years, and 61.5% of those over the age of 70 years (P less than .01).

Additionally, 56.4% of all subjects with diabetes (P less than .01), 59.0% of subjects with nonmelanoma skin cancer (P less than .03), and 58.1% of those with hepatocarcinoma (P less than .02) were also found to have cysts. Most striking, however, is that newer hardware and software permutations were able to detect cysts in 56.3% (Skyra) of patients who had them, compared with only 30.3% (Symphony) of patients who underwent MRI on older technology.

“The variable field strength” (1.5 T vs. 3 T) was not significantly related to the presence of PCLs,” Dr. Wallace and his coauthors concluded. “We believe this may be secondary to the lack of power of the analysis, because only 6% of the examinations were 3-T studies. Therefore, we speculate that this relationship may be confirmed if the number of 3-T studies increased.”

Males and females each made up roughly 50% of the study population, with a median age of 60 years and 85% being white. Additionally, 4% of subjects had a family history of pancreatic cancer, 12% had a personal history of solid organ transplant, and 53% had a personal history of smoking.

This study was funded by the Mayo Clinic. Dr. Wallace disclosed that he has received grant funding from Olympus, Boston Scientific, and Cosmo Pharmaceuticals, and travel support from Olympus. No other authors reported any financial disclosures.

[email protected]

As magnetic resonance imaging technology continues to advance year after year, so does MRI’s ability to accurately detect pancreatic cysts, according to a new study published in the April issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2015.08.038).

“To our knowledge, this is the first study to analyze the relationship between the technical improvements in imaging techniques (specifically, MRI) and the presence of incidentally found PCLs [pancreatic cystic lesions],” said the study authors, led by Dr. Michael B. Wallace of the Mayo Clinic in Jacksonville, Fla.

Dr. Wallace and his coinvestigators launched this retrospective descriptive study selecting the first 50 consecutive abdominal MRI patients at the Jacksonville Mayo Clinic during January and February of each year from 2005 through 2014, for a total of 500 cases who met inclusion criteria included in the study. Patients were excluded if they had preexisting symptomatic or asymptomatic pancreatitis, either acute or chronic, pancreatic masses, pancreatic cysts, pancreatic surgery, pancreatic symptoms, or any pancreas-related indications found by MRI.

The clinic underwent periodic MRI updates over the course of the 10-year study, along with requisite software updates to “take advantage of the new hardware technology,” the study explains. Major hardware improvements, provided by Siemens Medical Solutions USA, were Symphony/Sonata, Espree/Avanto, and Aera/Skyra, while software updates corresponding to each hardware update were VA, VB, and VD, respectively.

SOURCE: AMERICAN GASTROENTEROLOGICAL ASSOCIATION

Furthermore, each software update had other, smaller upgrades, leading to a total of 20 combinations of MRI hardware and software on which MRIs were performed over the 10 years. Every MRI taken included “an axial and a coronal T2-weighted single-shot (HASTE) pulse sequence [with] TR 1400-1500 ms, TE 82-99 ms, and slice thickness 5-7 mm (gap, 0.5-0.7 mm).” Each MRI was analyzed by a pancreatic MRI specialist to find incidental cysts.

The number of patients found with pancreatic cysts increased incrementally from 2005 to 2014, with 2010 being the year with the highest number. A total of 208 subjects (41.6%) were found to have incidental cysts, but only 44 of these cases were discovered in the original MRI. The presence of cysts was associated with older age in patients who had them; only 20% of all subjects under 50 years of age had cysts, compared to 32.4% of those between 50 and 60 years, 54.9% of those between 60 and 70 years, and 61.5% of those over the age of 70 years (P less than .01).

Additionally, 56.4% of all subjects with diabetes (P less than .01), 59.0% of subjects with nonmelanoma skin cancer (P less than .03), and 58.1% of those with hepatocarcinoma (P less than .02) were also found to have cysts. Most striking, however, is that newer hardware and software permutations were able to detect cysts in 56.3% (Skyra) of patients who had them, compared with only 30.3% (Symphony) of patients who underwent MRI on older technology.

“The variable field strength” (1.5 T vs. 3 T) was not significantly related to the presence of PCLs,” Dr. Wallace and his coauthors concluded. “We believe this may be secondary to the lack of power of the analysis, because only 6% of the examinations were 3-T studies. Therefore, we speculate that this relationship may be confirmed if the number of 3-T studies increased.”

Males and females each made up roughly 50% of the study population, with a median age of 60 years and 85% being white. Additionally, 4% of subjects had a family history of pancreatic cancer, 12% had a personal history of solid organ transplant, and 53% had a personal history of smoking.

This study was funded by the Mayo Clinic. Dr. Wallace disclosed that he has received grant funding from Olympus, Boston Scientific, and Cosmo Pharmaceuticals, and travel support from Olympus. No other authors reported any financial disclosures.

[email protected]

Minimally invasive endoscopic procedures are transforming gastrointestinal surgery by offering organ-sparing approaches for a range of pathologies. At the 2016 AGA Tech Summit, Dr. David Rattner updated attendees on three of these techniques – endoscopic submucosal dissection (ESD), peroral endoscopic myotomy (POEM), and endoscopic full-thickness resection (EFTR).

“It is likely that endoluminal treatments, combined with better understanding of molecular pathology, will decrease the need for radical surgical procedures for some common gastrointestinal conditions,” he said in an interview before the meeting, which is sponsored by the AGA Center for GI Innovation and Technology. Dr. Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital in Boston.

Dr. Jose Martinez put transorifice surgery in historical perspective and pointed the way forward in an accompanying presentation. “The collaboration with physicians and industry has really started to come along with the natural orifice approach,” said Dr. Martinez, professor of surgery at the University of Miami Health System.

Developed in the 1980s and substantially refined in the mid-2000s, ESD pioneered the endoscopic resection of entire intramucosal tumors without the need for open surgery. In a recent meta-analysis, ESD achieved significantly higher rates of en bloc resection than endoscopic mucosal resection (EMR), with significantly lower rates of local recurrence and comparable complication rates (World J Gastroenterol. 2014;20:8282-7).

ESD involves resecting the mucosa and much of the submucosa, while conserving the muscular layer of the esophagus. In contrast, during POEM, the surgeon intentionally divides the muscular layer, while the intact mucosa provides the barrier between the mediastinum or peritoneum and the esophageal lumen. The defining feature of POEM is the creation of a submucosal tunnel to access the muscle layer for myotomy without incising the skin.

POEM has been found highly successful for treating esophageal achalasia. In fact, in a recently published series of 500 cases, the success rate was 100%, even though the cohort included elderly patients and those with sigmoid esophagus and complex treatment histories (J Am Coll Surg. 2015;221:256-64). Two months post-treatment, average Eckardt scores had decreased by an average of 5.0, and lower esophageal sphincter pressures had fallen by nearly 50%. The adverse event rate was 3%, there were no fatalities, and improvements persisted 3 years later. “Nationwide, numerous centers have incorporated this technique and gotten significant positive results,” said Dr. Martinez.

“POEM will be shown to be as effective as any other currently existing therapy for the treatment of achalasia,” emphasized Dr. Rattner. Indeed, its success has sparked investigations of submucosal tunneling for other indications, such as tumor resection and pyloromyotomy for gastroparesis (World J Gastroenterol. 2014;20:17746-55).

Another cutting-edge technique is EFTR, described as a powerful tool not only for acquiring diagnostic tissue, but also for sparing some patients from surgery. Compared with ESD, it has the potential for higher diagnostic yield of full-thickness specimens, such as in cases of nonlifting adenomas, adenomas at difficult anatomic locations, T1-carcinomas, or submucosal colorectal tumors. For years, a lack of safe techniques and devices kept EFTR from entering routine clinical practice. But intensive research on natural orifice translumenal endoscopic surgery (NOTES) has helped propel innovations such as over-the-scope clips for closing incisions, and smaller, more maneuverable, over-the-scope full-thickness resection devices. Large-scale trials of EFTR are lacking, but in a recent report of 19 consecutive colonic submucosal tumors, EFTR enabled the removal of the entire tumor with capsule intact in 18 instances (Endoscopy. 2013;45[09]:770-3). Notably, colonic wall defects could be closed endoscopically in 16 of 18 cases.

“We are still a ways away from being able to perform EFTR on a routine basis, but new technologies are under development that will make this possible,” said Dr. Rattner. Agreeing that the future of transorifice surgery is bright and growing, Dr. Martinez said, “Strictures, obstructions, bleeding, foreign bodies are now fully resolved through endoscopic approaches.” 

Minimally invasive endoscopic procedures are transforming gastrointestinal surgery by offering organ-sparing approaches for a range of pathologies. At the 2016 AGA Tech Summit, Dr. David Rattner updated attendees on three of these techniques – endoscopic submucosal dissection (ESD), peroral endoscopic myotomy (POEM), and endoscopic full-thickness resection (EFTR).

“It is likely that endoluminal treatments, combined with better understanding of molecular pathology, will decrease the need for radical surgical procedures for some common gastrointestinal conditions,” he said in an interview before the meeting, which is sponsored by the AGA Center for GI Innovation and Technology. Dr. Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital in Boston.

Dr. Jose Martinez put transorifice surgery in historical perspective and pointed the way forward in an accompanying presentation. “The collaboration with physicians and industry has really started to come along with the natural orifice approach,” said Dr. Martinez, professor of surgery at the University of Miami Health System.

Developed in the 1980s and substantially refined in the mid-2000s, ESD pioneered the endoscopic resection of entire intramucosal tumors without the need for open surgery. In a recent meta-analysis, ESD achieved significantly higher rates of en bloc resection than endoscopic mucosal resection (EMR), with significantly lower rates of local recurrence and comparable complication rates (World J Gastroenterol. 2014;20:8282-7).

ESD involves resecting the mucosa and much of the submucosa, while conserving the muscular layer of the esophagus. In contrast, during POEM, the surgeon intentionally divides the muscular layer, while the intact mucosa provides the barrier between the mediastinum or peritoneum and the esophageal lumen. The defining feature of POEM is the creation of a submucosal tunnel to access the muscle layer for myotomy without incising the skin.

POEM has been found highly successful for treating esophageal achalasia. In fact, in a recently published series of 500 cases, the success rate was 100%, even though the cohort included elderly patients and those with sigmoid esophagus and complex treatment histories (J Am Coll Surg. 2015;221:256-64). Two months post-treatment, average Eckardt scores had decreased by an average of 5.0, and lower esophageal sphincter pressures had fallen by nearly 50%. The adverse event rate was 3%, there were no fatalities, and improvements persisted 3 years later. “Nationwide, numerous centers have incorporated this technique and gotten significant positive results,” said Dr. Martinez.

“POEM will be shown to be as effective as any other currently existing therapy for the treatment of achalasia,” emphasized Dr. Rattner. Indeed, its success has sparked investigations of submucosal tunneling for other indications, such as tumor resection and pyloromyotomy for gastroparesis (World J Gastroenterol. 2014;20:17746-55).

Another cutting-edge technique is EFTR, described as a powerful tool not only for acquiring diagnostic tissue, but also for sparing some patients from surgery. Compared with ESD, it has the potential for higher diagnostic yield of full-thickness specimens, such as in cases of nonlifting adenomas, adenomas at difficult anatomic locations, T1-carcinomas, or submucosal colorectal tumors. For years, a lack of safe techniques and devices kept EFTR from entering routine clinical practice. But intensive research on natural orifice translumenal endoscopic surgery (NOTES) has helped propel innovations such as over-the-scope clips for closing incisions, and smaller, more maneuverable, over-the-scope full-thickness resection devices. Large-scale trials of EFTR are lacking, but in a recent report of 19 consecutive colonic submucosal tumors, EFTR enabled the removal of the entire tumor with capsule intact in 18 instances (Endoscopy. 2013;45[09]:770-3). Notably, colonic wall defects could be closed endoscopically in 16 of 18 cases.

“We are still a ways away from being able to perform EFTR on a routine basis, but new technologies are under development that will make this possible,” said Dr. Rattner. Agreeing that the future of transorifice surgery is bright and growing, Dr. Martinez said, “Strictures, obstructions, bleeding, foreign bodies are now fully resolved through endoscopic approaches.” 

Minimally invasive endoscopic procedures are transforming gastrointestinal surgery by offering organ-sparing approaches for a range of pathologies. At the 2016 AGA Tech Summit, Dr. David Rattner updated attendees on three of these techniques – endoscopic submucosal dissection (ESD), peroral endoscopic myotomy (POEM), and endoscopic full-thickness resection (EFTR).

“It is likely that endoluminal treatments, combined with better understanding of molecular pathology, will decrease the need for radical surgical procedures for some common gastrointestinal conditions,” he said in an interview before the meeting, which is sponsored by the AGA Center for GI Innovation and Technology. Dr. Rattner is chief of the division of gastrointestinal and general surgery at Massachusetts General Hospital in Boston.

Dr. Jose Martinez put transorifice surgery in historical perspective and pointed the way forward in an accompanying presentation. “The collaboration with physicians and industry has really started to come along with the natural orifice approach,” said Dr. Martinez, professor of surgery at the University of Miami Health System.

Developed in the 1980s and substantially refined in the mid-2000s, ESD pioneered the endoscopic resection of entire intramucosal tumors without the need for open surgery. In a recent meta-analysis, ESD achieved significantly higher rates of en bloc resection than endoscopic mucosal resection (EMR), with significantly lower rates of local recurrence and comparable complication rates (World J Gastroenterol. 2014;20:8282-7).

ESD involves resecting the mucosa and much of the submucosa, while conserving the muscular layer of the esophagus. In contrast, during POEM, the surgeon intentionally divides the muscular layer, while the intact mucosa provides the barrier between the mediastinum or peritoneum and the esophageal lumen. The defining feature of POEM is the creation of a submucosal tunnel to access the muscle layer for myotomy without incising the skin.

POEM has been found highly successful for treating esophageal achalasia. In fact, in a recently published series of 500 cases, the success rate was 100%, even though the cohort included elderly patients and those with sigmoid esophagus and complex treatment histories (J Am Coll Surg. 2015;221:256-64). Two months post-treatment, average Eckardt scores had decreased by an average of 5.0, and lower esophageal sphincter pressures had fallen by nearly 50%. The adverse event rate was 3%, there were no fatalities, and improvements persisted 3 years later. “Nationwide, numerous centers have incorporated this technique and gotten significant positive results,” said Dr. Martinez.

“POEM will be shown to be as effective as any other currently existing therapy for the treatment of achalasia,” emphasized Dr. Rattner. Indeed, its success has sparked investigations of submucosal tunneling for other indications, such as tumor resection and pyloromyotomy for gastroparesis (World J Gastroenterol. 2014;20:17746-55).

Another cutting-edge technique is EFTR, described as a powerful tool not only for acquiring diagnostic tissue, but also for sparing some patients from surgery. Compared with ESD, it has the potential for higher diagnostic yield of full-thickness specimens, such as in cases of nonlifting adenomas, adenomas at difficult anatomic locations, T1-carcinomas, or submucosal colorectal tumors. For years, a lack of safe techniques and devices kept EFTR from entering routine clinical practice. But intensive research on natural orifice translumenal endoscopic surgery (NOTES) has helped propel innovations such as over-the-scope clips for closing incisions, and smaller, more maneuverable, over-the-scope full-thickness resection devices. Large-scale trials of EFTR are lacking, but in a recent report of 19 consecutive colonic submucosal tumors, EFTR enabled the removal of the entire tumor with capsule intact in 18 instances (Endoscopy. 2013;45[09]:770-3). Notably, colonic wall defects could be closed endoscopically in 16 of 18 cases.

“We are still a ways away from being able to perform EFTR on a routine basis, but new technologies are under development that will make this possible,” said Dr. Rattner. Agreeing that the future of transorifice surgery is bright and growing, Dr. Martinez said, “Strictures, obstructions, bleeding, foreign bodies are now fully resolved through endoscopic approaches.” 

Embattled scope maker Olympus Corp., already under federal investigation for its role in superbug outbreaks, has agreed to pay $646 million to resolve criminal and civil probes into illegal kickbacks and bribes to doctors and hospitals.

Federal prosecutors said Tuesday that the company’s settlement is the largest ever for violations of the U.S. anti-kickback law. A portion of the company’s payout, $22.8 million, will resolve foreign bribery allegations in Latin America.

U.S. investigators said the company’s “greed-fueled kickback scheme” from 2006 to 2011 used grants, consulting deals, trips to Japan, lavish gifts, and free equipment to induce influential doctors to order more Olympus devices at prominent hospitals and keep out competitors.

After a key doctor for a Midwest hospital system took a week-long trip to Japan and received a company grant, an Olympus vice president wrote an internal email in 2006 that said, “We have received all of the orders expected and have kept (a competitor) completely out of the (Midwestern hospital) system. Hooray!”

The federal complaint against Olympus mentioned similar scenarios at a prominent California institution and a New York medical center, but the exact names were redacted.

The violations produced about $600 million in sales and $230 million in gross profits for Olympus, federal officials said.

Federal prosecutors credited the help of a former compliance officer at Olympus, John Slowik, who filed a whistle-blower case against the company under seal in 2010.

Olympus agreed to a corporate-integrity agreement and the appointment of an independent monitor.

“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement. “Olympus is committed to complying with all laws and regulations and to adhering to our own rigorous code of conduct.”

Olympus has come under fire for failing to alert U.S. regulators and hospitals sooner about the risks of infection from its duodenoscopes, a gastrointestinal scope that has proven difficult to clean of dangerous bacteria because of its intricate design.

A Senate investigation released in January identified 19 scope-related outbreaks at U.S. medical centers during 2012-2015 that sickened nearly 200 patients with drug-resistant infections.

Olympus announced in January it would recall its duodenoscopes nationwide and make repairs to improve patient safety. The company controls 85% of the U.S. market for gastrointestinal scopes.

Last year, the Tokyo company disclosed it had received a subpoena from federal prosecutors in March 2015 seeking “information relating to duodenoscopes that Olympus manufactures and sells.”

This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Embattled scope maker Olympus Corp., already under federal investigation for its role in superbug outbreaks, has agreed to pay $646 million to resolve criminal and civil probes into illegal kickbacks and bribes to doctors and hospitals.

Federal prosecutors said Tuesday that the company’s settlement is the largest ever for violations of the U.S. anti-kickback law. A portion of the company’s payout, $22.8 million, will resolve foreign bribery allegations in Latin America.

U.S. investigators said the company’s “greed-fueled kickback scheme” from 2006 to 2011 used grants, consulting deals, trips to Japan, lavish gifts, and free equipment to induce influential doctors to order more Olympus devices at prominent hospitals and keep out competitors.

After a key doctor for a Midwest hospital system took a week-long trip to Japan and received a company grant, an Olympus vice president wrote an internal email in 2006 that said, “We have received all of the orders expected and have kept (a competitor) completely out of the (Midwestern hospital) system. Hooray!”

The federal complaint against Olympus mentioned similar scenarios at a prominent California institution and a New York medical center, but the exact names were redacted.

The violations produced about $600 million in sales and $230 million in gross profits for Olympus, federal officials said.

Federal prosecutors credited the help of a former compliance officer at Olympus, John Slowik, who filed a whistle-blower case against the company under seal in 2010.

Olympus agreed to a corporate-integrity agreement and the appointment of an independent monitor.

“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement. “Olympus is committed to complying with all laws and regulations and to adhering to our own rigorous code of conduct.”

Olympus has come under fire for failing to alert U.S. regulators and hospitals sooner about the risks of infection from its duodenoscopes, a gastrointestinal scope that has proven difficult to clean of dangerous bacteria because of its intricate design.

A Senate investigation released in January identified 19 scope-related outbreaks at U.S. medical centers during 2012-2015 that sickened nearly 200 patients with drug-resistant infections.

Olympus announced in January it would recall its duodenoscopes nationwide and make repairs to improve patient safety. The company controls 85% of the U.S. market for gastrointestinal scopes.

Last year, the Tokyo company disclosed it had received a subpoena from federal prosecutors in March 2015 seeking “information relating to duodenoscopes that Olympus manufactures and sells.”

This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Embattled scope maker Olympus Corp., already under federal investigation for its role in superbug outbreaks, has agreed to pay $646 million to resolve criminal and civil probes into illegal kickbacks and bribes to doctors and hospitals.

Federal prosecutors said Tuesday that the company’s settlement is the largest ever for violations of the U.S. anti-kickback law. A portion of the company’s payout, $22.8 million, will resolve foreign bribery allegations in Latin America.

U.S. investigators said the company’s “greed-fueled kickback scheme” from 2006 to 2011 used grants, consulting deals, trips to Japan, lavish gifts, and free equipment to induce influential doctors to order more Olympus devices at prominent hospitals and keep out competitors.

After a key doctor for a Midwest hospital system took a week-long trip to Japan and received a company grant, an Olympus vice president wrote an internal email in 2006 that said, “We have received all of the orders expected and have kept (a competitor) completely out of the (Midwestern hospital) system. Hooray!”

The federal complaint against Olympus mentioned similar scenarios at a prominent California institution and a New York medical center, but the exact names were redacted.

The violations produced about $600 million in sales and $230 million in gross profits for Olympus, federal officials said.

Federal prosecutors credited the help of a former compliance officer at Olympus, John Slowik, who filed a whistle-blower case against the company under seal in 2010.

Olympus agreed to a corporate-integrity agreement and the appointment of an independent monitor.

“Olympus leadership acknowledges the company’s responsibility for the past conduct, which does not represent the values of Olympus or its employees,” Nacho Abia, chief executive of the Olympus Corp. of the Americas unit in Center Valley, Pa., said in a statement. “Olympus is committed to complying with all laws and regulations and to adhering to our own rigorous code of conduct.”

Olympus has come under fire for failing to alert U.S. regulators and hospitals sooner about the risks of infection from its duodenoscopes, a gastrointestinal scope that has proven difficult to clean of dangerous bacteria because of its intricate design.

A Senate investigation released in January identified 19 scope-related outbreaks at U.S. medical centers during 2012-2015 that sickened nearly 200 patients with drug-resistant infections.

Olympus announced in January it would recall its duodenoscopes nationwide and make repairs to improve patient safety. The company controls 85% of the U.S. market for gastrointestinal scopes.

Last year, the Tokyo company disclosed it had received a subpoena from federal prosecutors in March 2015 seeking “information relating to duodenoscopes that Olympus manufactures and sells.”

This article was originally published by Kaiser Health News, a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

PENTAX, the manufacturer of the ED-3490TK video duodenoscope, has issued updated validated manual reprocessing instructions to replace those provided in the original device labeling in response to a Food and Drug Administration Safety Communication released last February concerning the design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes and the risk of multidrug-resistant bacterial infections.

The FDA has reviewed these updated reprocessing instructions and recommends that staff be trained to implement them as soon as possible. Several changes have been made to the protocol for precleaning, manual cleaning, and high-level disinfection that the FDA found to be adequate.

Olympus, the manufacturer of the TJF-Q180V duodenoscope has also issued updated manual reprocessing instructions.

In February 2015, the FDA first announced that the agency had received reports of multidrug-resistant bacterial infections in patients who had undergone ERCP with duodenoscopes that had been cleaned and disinfected properly (according to manufacturer instructions) and determined that the “complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.”

Since then, the FDA has been working with duodenoscope manufacturers to revise their manual reprocessing instructions to devise standard procedures to eliminate the risk of spreading infection between patients and better survey any contamination of the duodenoscopes.

The American Gastroenterological Association's Center for GI Innovation and Technology has been working closely with the FDA and device manufacturers to develop a path forward with zero device-associated infections.

Adverse events associated with duodenoscopes should be reported to the FDA’s MedWatch program at 800-332-1088 or www.accessdata.fda.gov/scripts/medwatch.

PENTAX, the manufacturer of the ED-3490TK video duodenoscope, has issued updated validated manual reprocessing instructions to replace those provided in the original device labeling in response to a Food and Drug Administration Safety Communication released last February concerning the design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes and the risk of multidrug-resistant bacterial infections.

The FDA has reviewed these updated reprocessing instructions and recommends that staff be trained to implement them as soon as possible. Several changes have been made to the protocol for precleaning, manual cleaning, and high-level disinfection that the FDA found to be adequate.

Olympus, the manufacturer of the TJF-Q180V duodenoscope has also issued updated manual reprocessing instructions.

In February 2015, the FDA first announced that the agency had received reports of multidrug-resistant bacterial infections in patients who had undergone ERCP with duodenoscopes that had been cleaned and disinfected properly (according to manufacturer instructions) and determined that the “complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.”

Since then, the FDA has been working with duodenoscope manufacturers to revise their manual reprocessing instructions to devise standard procedures to eliminate the risk of spreading infection between patients and better survey any contamination of the duodenoscopes.

The American Gastroenterological Association's Center for GI Innovation and Technology has been working closely with the FDA and device manufacturers to develop a path forward with zero device-associated infections.

Adverse events associated with duodenoscopes should be reported to the FDA’s MedWatch program at 800-332-1088 or www.accessdata.fda.gov/scripts/medwatch.

PENTAX, the manufacturer of the ED-3490TK video duodenoscope, has issued updated validated manual reprocessing instructions to replace those provided in the original device labeling in response to a Food and Drug Administration Safety Communication released last February concerning the design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes and the risk of multidrug-resistant bacterial infections.

The FDA has reviewed these updated reprocessing instructions and recommends that staff be trained to implement them as soon as possible. Several changes have been made to the protocol for precleaning, manual cleaning, and high-level disinfection that the FDA found to be adequate.

Olympus, the manufacturer of the TJF-Q180V duodenoscope has also issued updated manual reprocessing instructions.

In February 2015, the FDA first announced that the agency had received reports of multidrug-resistant bacterial infections in patients who had undergone ERCP with duodenoscopes that had been cleaned and disinfected properly (according to manufacturer instructions) and determined that the “complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.”

Since then, the FDA has been working with duodenoscope manufacturers to revise their manual reprocessing instructions to devise standard procedures to eliminate the risk of spreading infection between patients and better survey any contamination of the duodenoscopes.

The American Gastroenterological Association's Center for GI Innovation and Technology has been working closely with the FDA and device manufacturers to develop a path forward with zero device-associated infections.

Adverse events associated with duodenoscopes should be reported to the FDA’s MedWatch program at 800-332-1088 or www.accessdata.fda.gov/scripts/medwatch.