User login
Blood donor age, sex do not affect recipient survival
The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.
A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.
A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.
In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).
“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.
“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.
“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.
The findings of Edgren et al. provide reassurance regarding the safety of current transfusion practice.
They present a convincing argument that differences in the statistical approach for controlling confounding likely explained the discrepant results of the Canadian study and their study.
This subtle confounding stems from the fact that increased transfusions expose the recipient to a greater total number of blood products, which in turn is associated with higher comorbidity, greater severity of illness, and higher mortality.
Nareg Roubinian, MD, is at the Blood Systems Research Institute, San Francisco, and in the division of research at Kaiser Permanente Northern California, Oakland. He and his associates reported having no relevant financial disclosures. They made these remarks in an invited commentary accompanying Dr. Edgren’s report (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0914).
The findings of Edgren et al. provide reassurance regarding the safety of current transfusion practice.
They present a convincing argument that differences in the statistical approach for controlling confounding likely explained the discrepant results of the Canadian study and their study.
This subtle confounding stems from the fact that increased transfusions expose the recipient to a greater total number of blood products, which in turn is associated with higher comorbidity, greater severity of illness, and higher mortality.
Nareg Roubinian, MD, is at the Blood Systems Research Institute, San Francisco, and in the division of research at Kaiser Permanente Northern California, Oakland. He and his associates reported having no relevant financial disclosures. They made these remarks in an invited commentary accompanying Dr. Edgren’s report (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0914).
The findings of Edgren et al. provide reassurance regarding the safety of current transfusion practice.
They present a convincing argument that differences in the statistical approach for controlling confounding likely explained the discrepant results of the Canadian study and their study.
This subtle confounding stems from the fact that increased transfusions expose the recipient to a greater total number of blood products, which in turn is associated with higher comorbidity, greater severity of illness, and higher mortality.
Nareg Roubinian, MD, is at the Blood Systems Research Institute, San Francisco, and in the division of research at Kaiser Permanente Northern California, Oakland. He and his associates reported having no relevant financial disclosures. They made these remarks in an invited commentary accompanying Dr. Edgren’s report (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0914).
The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.
A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.
A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.
In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).
“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.
“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.
“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.
The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.
A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.
A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.
In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).
“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.
“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.
“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.
Key clinical point: The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation.
Major finding: The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99.
Data source: A retrospective cohort study involving 968,264 transfusion recipients in Sweden and Denmark during a 10-year period.
Disclosures: The Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Society for Medical Research, Karolinska Institutet’s Strategic Research Program, and the Danish Council for Independent Research supported the study. Dr. Edgren and his associates reported having no relevant financial disclosures.
Three-strategy combo reduces pancreatoduodenectomy fistula risk
MIAMI BEACH – Pancreaticojejunostomy reconstruction, use of stents, and avoidance of prophylactic octreotide, especially in combination, could reduce the fistula rate associated with pancreatoduodenectomy.
Failure of the anastomosis is “of greatest concern” to surgeons performing a pancreatoduodenectomy, said Brett L. Ecker, MD, a surgical resident at the University of Pennsylvania, Philadelphia.
“There is no shortage of high-quality data to help guide the use of [fistula reduction] strategies,” he added. However, “the utility of these strategies in patients most vulnerable to fistula … has rarely been particularly explored.”
Dr. Ecker and his colleagues conducted a study with 62 surgeons at 17 institutions to compare various fistula mitigation strategies in this higher-risk population. They assessed surgical reconstruction, dunking, tissue patches, intraperitoneal drains, stents, prophylactic octreotide, and use of tissue sealants.
“Ultimately, we want to know the best way to deal with this high-stakes situation, and whether outcomes might be optimized by bundling these proactive strategies,” Dr. Ecker explained.
“We found the combination of externalized stents and PJ [pancreaticojejunostomy] reconstruction with the omission of prophylactic octreotide was associated with significant improvements in fistula that exceeded the benefit of any individual mitigation approach or any other combination of strategies,” he said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
“The mitigation of risk in real-life practice is often the result of multiple moving parts,” Dr. Ecker said. “The best outcomes [may result from] the synergistic effects of multiple strategies.”
Of the approximately 10% of patients with a Fistula Risk Score of 7-10, 152 ended up with clinically relevant postoperative pancreatic fistula (CR-POPF). “An FRS score of 7 or higher is associated with worse outcomes, including a fistula rate approaching 30%,” Dr. Ecker said. Grade B or C fistula based on International Study Group on Pancreatic Surgery criteria were considered clinically relevant. All patients had surgery from 2003 to 2016 in the retrospective, multinational study.
“This represents the only series of high-risk cases where current international standards were used to define both the risk and the outcome,” he noted.
“Almost all [of the 522] patients had a soft gland and a small duct, a median of 2 mm,” Dr. Ecker added. “High-risk pathology was common, in 86%.”
Surgeons contributing to the series were at high-volume centers and had performed more than 200 Whipple procedures in their careers. “Both institutional and surgeon volume were associated with improved fistula outcomes,” Dr. Ecker said. “We found that intraperitoneal drains were not associated with improved fistula outcomes, but that is limited by the fact that drains were rarely omitted in these cases.”
Four strategies compared
The investigators compared the outcomes of four fistula strategies among the patients considered high risk prior to surgery. When they combined pancreaticogastrostomy, prophylactic octreotide, and no stent, the CR-POPF rate was 47%. “This was associated with an alarming fistula rate approaching 50%,” Dr. Ecker said.
When surgeons combined pancreaticojejunostomy, octreotide, and no stent, the CR-POPF rate declined to 34%. Furthermore, pancreaticojejunostomy without octreotide or a stent yielded a 26% CR-POPF rate.
Ultimately, the most effective strategy to avoid clinically relevant fistula was pancreaticojejunostomy with an external stent and no octreotide.
“The use of PJ reconstruction with an external stent and omission of octreotide was associated with a fistula rate of about 13%, which was a greater than 50% risk reduction from the overall cohort,” Dr. Ecker said.
The researchers also performed propensity score matching to reduce bias associated with surgeon or patient factors. They matched 167 participants in the study with 155 controls. Dr. Ecker said, “Still, we observed that patients managed this way had significantly lower fistula rates.”
“This is an excellent paper and an important topic,” said study discussant Michael L. Kendrick, MD, a general surgeon at the Mayo Clinic in Rochester, Minn.
“At our institution, we’ve used the same Fistula Risk Score and found it very helpful for a mitigation strategy in a separate protocol, and we found that reduced our leak rates as well,” Dr. Kendrick noted.
Dr. Ecker and Dr. Kendrick had no relevant disclosures.
MIAMI BEACH – Pancreaticojejunostomy reconstruction, use of stents, and avoidance of prophylactic octreotide, especially in combination, could reduce the fistula rate associated with pancreatoduodenectomy.
Failure of the anastomosis is “of greatest concern” to surgeons performing a pancreatoduodenectomy, said Brett L. Ecker, MD, a surgical resident at the University of Pennsylvania, Philadelphia.
“There is no shortage of high-quality data to help guide the use of [fistula reduction] strategies,” he added. However, “the utility of these strategies in patients most vulnerable to fistula … has rarely been particularly explored.”
Dr. Ecker and his colleagues conducted a study with 62 surgeons at 17 institutions to compare various fistula mitigation strategies in this higher-risk population. They assessed surgical reconstruction, dunking, tissue patches, intraperitoneal drains, stents, prophylactic octreotide, and use of tissue sealants.
“Ultimately, we want to know the best way to deal with this high-stakes situation, and whether outcomes might be optimized by bundling these proactive strategies,” Dr. Ecker explained.
“We found the combination of externalized stents and PJ [pancreaticojejunostomy] reconstruction with the omission of prophylactic octreotide was associated with significant improvements in fistula that exceeded the benefit of any individual mitigation approach or any other combination of strategies,” he said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
“The mitigation of risk in real-life practice is often the result of multiple moving parts,” Dr. Ecker said. “The best outcomes [may result from] the synergistic effects of multiple strategies.”
Of the approximately 10% of patients with a Fistula Risk Score of 7-10, 152 ended up with clinically relevant postoperative pancreatic fistula (CR-POPF). “An FRS score of 7 or higher is associated with worse outcomes, including a fistula rate approaching 30%,” Dr. Ecker said. Grade B or C fistula based on International Study Group on Pancreatic Surgery criteria were considered clinically relevant. All patients had surgery from 2003 to 2016 in the retrospective, multinational study.
“This represents the only series of high-risk cases where current international standards were used to define both the risk and the outcome,” he noted.
“Almost all [of the 522] patients had a soft gland and a small duct, a median of 2 mm,” Dr. Ecker added. “High-risk pathology was common, in 86%.”
Surgeons contributing to the series were at high-volume centers and had performed more than 200 Whipple procedures in their careers. “Both institutional and surgeon volume were associated with improved fistula outcomes,” Dr. Ecker said. “We found that intraperitoneal drains were not associated with improved fistula outcomes, but that is limited by the fact that drains were rarely omitted in these cases.”
Four strategies compared
The investigators compared the outcomes of four fistula strategies among the patients considered high risk prior to surgery. When they combined pancreaticogastrostomy, prophylactic octreotide, and no stent, the CR-POPF rate was 47%. “This was associated with an alarming fistula rate approaching 50%,” Dr. Ecker said.
When surgeons combined pancreaticojejunostomy, octreotide, and no stent, the CR-POPF rate declined to 34%. Furthermore, pancreaticojejunostomy without octreotide or a stent yielded a 26% CR-POPF rate.
Ultimately, the most effective strategy to avoid clinically relevant fistula was pancreaticojejunostomy with an external stent and no octreotide.
“The use of PJ reconstruction with an external stent and omission of octreotide was associated with a fistula rate of about 13%, which was a greater than 50% risk reduction from the overall cohort,” Dr. Ecker said.
The researchers also performed propensity score matching to reduce bias associated with surgeon or patient factors. They matched 167 participants in the study with 155 controls. Dr. Ecker said, “Still, we observed that patients managed this way had significantly lower fistula rates.”
“This is an excellent paper and an important topic,” said study discussant Michael L. Kendrick, MD, a general surgeon at the Mayo Clinic in Rochester, Minn.
“At our institution, we’ve used the same Fistula Risk Score and found it very helpful for a mitigation strategy in a separate protocol, and we found that reduced our leak rates as well,” Dr. Kendrick noted.
Dr. Ecker and Dr. Kendrick had no relevant disclosures.
MIAMI BEACH – Pancreaticojejunostomy reconstruction, use of stents, and avoidance of prophylactic octreotide, especially in combination, could reduce the fistula rate associated with pancreatoduodenectomy.
Failure of the anastomosis is “of greatest concern” to surgeons performing a pancreatoduodenectomy, said Brett L. Ecker, MD, a surgical resident at the University of Pennsylvania, Philadelphia.
“There is no shortage of high-quality data to help guide the use of [fistula reduction] strategies,” he added. However, “the utility of these strategies in patients most vulnerable to fistula … has rarely been particularly explored.”
Dr. Ecker and his colleagues conducted a study with 62 surgeons at 17 institutions to compare various fistula mitigation strategies in this higher-risk population. They assessed surgical reconstruction, dunking, tissue patches, intraperitoneal drains, stents, prophylactic octreotide, and use of tissue sealants.
“Ultimately, we want to know the best way to deal with this high-stakes situation, and whether outcomes might be optimized by bundling these proactive strategies,” Dr. Ecker explained.
“We found the combination of externalized stents and PJ [pancreaticojejunostomy] reconstruction with the omission of prophylactic octreotide was associated with significant improvements in fistula that exceeded the benefit of any individual mitigation approach or any other combination of strategies,” he said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
“The mitigation of risk in real-life practice is often the result of multiple moving parts,” Dr. Ecker said. “The best outcomes [may result from] the synergistic effects of multiple strategies.”
Of the approximately 10% of patients with a Fistula Risk Score of 7-10, 152 ended up with clinically relevant postoperative pancreatic fistula (CR-POPF). “An FRS score of 7 or higher is associated with worse outcomes, including a fistula rate approaching 30%,” Dr. Ecker said. Grade B or C fistula based on International Study Group on Pancreatic Surgery criteria were considered clinically relevant. All patients had surgery from 2003 to 2016 in the retrospective, multinational study.
“This represents the only series of high-risk cases where current international standards were used to define both the risk and the outcome,” he noted.
“Almost all [of the 522] patients had a soft gland and a small duct, a median of 2 mm,” Dr. Ecker added. “High-risk pathology was common, in 86%.”
Surgeons contributing to the series were at high-volume centers and had performed more than 200 Whipple procedures in their careers. “Both institutional and surgeon volume were associated with improved fistula outcomes,” Dr. Ecker said. “We found that intraperitoneal drains were not associated with improved fistula outcomes, but that is limited by the fact that drains were rarely omitted in these cases.”
Four strategies compared
The investigators compared the outcomes of four fistula strategies among the patients considered high risk prior to surgery. When they combined pancreaticogastrostomy, prophylactic octreotide, and no stent, the CR-POPF rate was 47%. “This was associated with an alarming fistula rate approaching 50%,” Dr. Ecker said.
When surgeons combined pancreaticojejunostomy, octreotide, and no stent, the CR-POPF rate declined to 34%. Furthermore, pancreaticojejunostomy without octreotide or a stent yielded a 26% CR-POPF rate.
Ultimately, the most effective strategy to avoid clinically relevant fistula was pancreaticojejunostomy with an external stent and no octreotide.
“The use of PJ reconstruction with an external stent and omission of octreotide was associated with a fistula rate of about 13%, which was a greater than 50% risk reduction from the overall cohort,” Dr. Ecker said.
The researchers also performed propensity score matching to reduce bias associated with surgeon or patient factors. They matched 167 participants in the study with 155 controls. Dr. Ecker said, “Still, we observed that patients managed this way had significantly lower fistula rates.”
“This is an excellent paper and an important topic,” said study discussant Michael L. Kendrick, MD, a general surgeon at the Mayo Clinic in Rochester, Minn.
“At our institution, we’ve used the same Fistula Risk Score and found it very helpful for a mitigation strategy in a separate protocol, and we found that reduced our leak rates as well,” Dr. Kendrick noted.
Dr. Ecker and Dr. Kendrick had no relevant disclosures.
AT AHPBA 2017
Key clinical point: Reconstruction, use of stents, and avoidance of octreotide, especially in combination, could reduce the fistula rate associated with pancreatoduodenectomy.
Major finding: The incidence of fistula decreased from 33% to 13% by combining the three strategies.
Data source: Multicenter retrospective study from 2003 to 2016 with 522 patients undergoing pancreatoduodenectomy.
Disclosures: Dr. Ecker and Dr. Kendrick had no relevant disclosures.
Debulking called reasonable for unresectable liver cancer
MIAMI BEACH – Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.
Liver debulking for patients with grossly unresectable disease is therefore an option that may extend survival, the study researchers said.
“Surgical resection offers the best chance for long-term survival but may not be technically feasible for all our patients,” said Fabio Bagante, MD, a resident at the University of Verona (Italy). “Debulking neuroendocrine liver metastases has been proposed as an alternative.”
Dr. Bagante and coinvestigators compared outcomes between 180 patients who had debulking surgery (defined as an R2 outcome) and 449 who underwent curative intent resection (R0 or R1). Patients had surgery between 1990 and 2015 at eight institutions, and the primary outcome was overall survival. The mean follow-up was 51 months; during that time, 174 patients died.
The 5-year overall survival was 72% in the debulking group and 89% in the curative intent group. The 10-year overall survival was 41% in the debulking group and 77% among the curative intent surgery patients.
“Debulking operations for neuroendocrine liver metastases provide lower but reasonable long-term survival, compared with patients who underwent curative intent,” Dr. Bagante said.
“Nearly 3 in 10 patients underwent debulking surgery,” Dr. Bagante said. “It was more common among the elderly, males with symptomatic disease, and patients with greater liver involvement.”
Patients in the liver-debulking groups were also significantly more likely to have high–tumor grade disease, 35%, versus 13% of the curative intent resection group (P less than .001). They were also more likely to have metastatic disease, with an N1 rate of 73% versus 52% (P less than .001).
“Great work. Thanks for presenting this topic. It’s quite a debated topic,” said study discussant Aaron Lee, DO, of the department of general surgery at Cleveland Clinic Florida in Weston. “I looked at your data on asymptomatic patients who had a 5-year survival of 60%; U.K. data show [the] same survival without any intervention.” He asked Dr. Bagante to comment on operating on patients without any symptoms.
“Regarding the role of symptoms as a predictor of survival, there are many papers in the literature debating what are the true predictors of survival,” Dr. Bagante noted. “We don’t think [symptoms have an] impact; our data do not demonstrate that. We think the biologic behavior of the disease, the impact of the progression of the disease, and the grade of the tumor, [indicated by] Ki-67, could have more of a role.”
MIAMI BEACH – Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.
Liver debulking for patients with grossly unresectable disease is therefore an option that may extend survival, the study researchers said.
“Surgical resection offers the best chance for long-term survival but may not be technically feasible for all our patients,” said Fabio Bagante, MD, a resident at the University of Verona (Italy). “Debulking neuroendocrine liver metastases has been proposed as an alternative.”
Dr. Bagante and coinvestigators compared outcomes between 180 patients who had debulking surgery (defined as an R2 outcome) and 449 who underwent curative intent resection (R0 or R1). Patients had surgery between 1990 and 2015 at eight institutions, and the primary outcome was overall survival. The mean follow-up was 51 months; during that time, 174 patients died.
The 5-year overall survival was 72% in the debulking group and 89% in the curative intent group. The 10-year overall survival was 41% in the debulking group and 77% among the curative intent surgery patients.
“Debulking operations for neuroendocrine liver metastases provide lower but reasonable long-term survival, compared with patients who underwent curative intent,” Dr. Bagante said.
“Nearly 3 in 10 patients underwent debulking surgery,” Dr. Bagante said. “It was more common among the elderly, males with symptomatic disease, and patients with greater liver involvement.”
Patients in the liver-debulking groups were also significantly more likely to have high–tumor grade disease, 35%, versus 13% of the curative intent resection group (P less than .001). They were also more likely to have metastatic disease, with an N1 rate of 73% versus 52% (P less than .001).
“Great work. Thanks for presenting this topic. It’s quite a debated topic,” said study discussant Aaron Lee, DO, of the department of general surgery at Cleveland Clinic Florida in Weston. “I looked at your data on asymptomatic patients who had a 5-year survival of 60%; U.K. data show [the] same survival without any intervention.” He asked Dr. Bagante to comment on operating on patients without any symptoms.
“Regarding the role of symptoms as a predictor of survival, there are many papers in the literature debating what are the true predictors of survival,” Dr. Bagante noted. “We don’t think [symptoms have an] impact; our data do not demonstrate that. We think the biologic behavior of the disease, the impact of the progression of the disease, and the grade of the tumor, [indicated by] Ki-67, could have more of a role.”
MIAMI BEACH – Cytoreductive debulking surgery for neuroendocrine liver metastases provides a lower but “reasonable” long-term survival, compared with curative intent surgery, according to results of a study presented at the annual meeting of the Americas Hepatico-Pancreato-Biliary Association.
Liver debulking for patients with grossly unresectable disease is therefore an option that may extend survival, the study researchers said.
“Surgical resection offers the best chance for long-term survival but may not be technically feasible for all our patients,” said Fabio Bagante, MD, a resident at the University of Verona (Italy). “Debulking neuroendocrine liver metastases has been proposed as an alternative.”
Dr. Bagante and coinvestigators compared outcomes between 180 patients who had debulking surgery (defined as an R2 outcome) and 449 who underwent curative intent resection (R0 or R1). Patients had surgery between 1990 and 2015 at eight institutions, and the primary outcome was overall survival. The mean follow-up was 51 months; during that time, 174 patients died.
The 5-year overall survival was 72% in the debulking group and 89% in the curative intent group. The 10-year overall survival was 41% in the debulking group and 77% among the curative intent surgery patients.
“Debulking operations for neuroendocrine liver metastases provide lower but reasonable long-term survival, compared with patients who underwent curative intent,” Dr. Bagante said.
“Nearly 3 in 10 patients underwent debulking surgery,” Dr. Bagante said. “It was more common among the elderly, males with symptomatic disease, and patients with greater liver involvement.”
Patients in the liver-debulking groups were also significantly more likely to have high–tumor grade disease, 35%, versus 13% of the curative intent resection group (P less than .001). They were also more likely to have metastatic disease, with an N1 rate of 73% versus 52% (P less than .001).
“Great work. Thanks for presenting this topic. It’s quite a debated topic,” said study discussant Aaron Lee, DO, of the department of general surgery at Cleveland Clinic Florida in Weston. “I looked at your data on asymptomatic patients who had a 5-year survival of 60%; U.K. data show [the] same survival without any intervention.” He asked Dr. Bagante to comment on operating on patients without any symptoms.
“Regarding the role of symptoms as a predictor of survival, there are many papers in the literature debating what are the true predictors of survival,” Dr. Bagante noted. “We don’t think [symptoms have an] impact; our data do not demonstrate that. We think the biologic behavior of the disease, the impact of the progression of the disease, and the grade of the tumor, [indicated by] Ki-67, could have more of a role.”
AT AHPBA 2017
Key clinical point:
Major finding: The 10-year overall survival was 77% in the curative intent surgery group, compared with 41% among the debulking patients.
Data source: A retrospective database study of 629 people with neuroendocrine liver metastases.
Disclosures: Dr. Bagante and Dr. Lee had no relevant financial disclosures.
Same-day discharge for lap hiatal procedures found feasible, safe
HOUSTON – Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.
“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.
The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.
The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.
“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”
The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”
Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.
With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.
Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.
Dr. Molina reported having no financial disclosures.
HOUSTON – Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.
“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.
The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.
The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.
“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”
The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”
Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.
With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.
Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.
Dr. Molina reported having no financial disclosures.
HOUSTON – Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.
“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.
The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.
The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.
“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”
The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”
Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.
With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.
Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.
Dr. Molina reported having no financial disclosures.
AT SAGES 2017
Key clinical point: Same-day surgery for benign laparoscopic hiatal procedures have outcomes comparable with those of inpatient procedures.
Major finding: Postoperative complications were 9.2% for outpatient operations vs. 19% for inpatient, and 81.7% of patients who had same-day surgery did not have an unplanned admission.
Data source: Retrospective single-center study of 261 patients who had inpatient and outpatient laparoscopic hiatal procedures from April 2011 to August 2016.
Disclosures: Dr. Molina-Franjola reported having no financial disclosures.
Postsurgical O2 may cut AHI events
Postoperative oxygen therapy in patients with previously undetected obstructive sleep apnea (OSA) led to a reduction in apnea-hypopnea index (AHI) events per hour with no increase in apnea-hypopnea event duration.
The results suggest that postoperative oxygen could be useful in patients with OSA who refuse continuous positive airway pressure (CPAP) therapy, those with newly diagnosed OSA, and those with suspected OSA.
The researchers set out to determine if postoperative oxygen therapy could improve oxygenation in patients with previously undiagnosed OSA, reasoning that the intervention could reduce adverse events.
The study, published in CHEST (2017 March;151[3]:597-611), provided generally good news, but with a caveat: “Essentially we are saying, yes, if you give supplemental oxygen, you improve oxygenation of the patient. But overall we have to be careful because a significant number of patients have significant carbon dioxide retention when receiving supplemental oxygen. So we have to monitor patients – not just oxygen, but we may have to monitor carbon dioxide levels, too,” said lead study author Frances Chung, MBBS, professor of anesthesiology at the University of Toronto and Toronto Western Hospital.
The researchers randomized 123 patients with an AHI of at least five events per hour to postoperative oxygen (3 L/min for 3 nights via nasal prongs) or no postoperative oxygen.
On the third night, the oxygen group had a higher average oxygen saturation than controls (95.2% plus or minus 3.2% vs. 91.4% plus or minus 3.5%; P less than .0001) and a lower oxygen desaturation index (median, 2.3 events per hour vs. median, 18.5; P less than .0001).
A lower number of AHI events per hour occurred in the oxygen group (median, 8.0) than in the control group (median, 15.6; P = .016).
On average, the longest apnea-hypopnea event (median, 33.8 seconds) was shorter for a patient on oxygen, compared with a patient who did not receive oxygen (median, 49.6 seconds; P = .002).
But one finding surprised the researchers and led to some concern: Across both groups, 11.4% of patients experienced substantial CO2 retention. Specifically, for at least 10% of 1 of the nights, these patients had a partial pressure of CO2 of at least 55 mm Hg, according to measurements taken with a transcutaneous CO2 monitor. Of the 14 patients who experienced this event, 13 were receiving oxygen.
Dr. Chung said the results argue strongly for postsurgical oxygen in patients with OSA, who are known to be at increased risk for complications. “We are not doing something about it, and we should be doing something. Because one death from a complication is too many,” she said.
The study was funded by the University Health Network Foundation, Toronto, and the University of Toronto. Dr. Chung reported receiving research grant support from Ontario Ministry of Health Innovation Grant, University Health Network Foundation, ResMed Foundation, Acacia, and Medtronic.
Postoperative oxygen therapy in patients with previously undetected obstructive sleep apnea (OSA) led to a reduction in apnea-hypopnea index (AHI) events per hour with no increase in apnea-hypopnea event duration.
The results suggest that postoperative oxygen could be useful in patients with OSA who refuse continuous positive airway pressure (CPAP) therapy, those with newly diagnosed OSA, and those with suspected OSA.
The researchers set out to determine if postoperative oxygen therapy could improve oxygenation in patients with previously undiagnosed OSA, reasoning that the intervention could reduce adverse events.
The study, published in CHEST (2017 March;151[3]:597-611), provided generally good news, but with a caveat: “Essentially we are saying, yes, if you give supplemental oxygen, you improve oxygenation of the patient. But overall we have to be careful because a significant number of patients have significant carbon dioxide retention when receiving supplemental oxygen. So we have to monitor patients – not just oxygen, but we may have to monitor carbon dioxide levels, too,” said lead study author Frances Chung, MBBS, professor of anesthesiology at the University of Toronto and Toronto Western Hospital.
The researchers randomized 123 patients with an AHI of at least five events per hour to postoperative oxygen (3 L/min for 3 nights via nasal prongs) or no postoperative oxygen.
On the third night, the oxygen group had a higher average oxygen saturation than controls (95.2% plus or minus 3.2% vs. 91.4% plus or minus 3.5%; P less than .0001) and a lower oxygen desaturation index (median, 2.3 events per hour vs. median, 18.5; P less than .0001).
A lower number of AHI events per hour occurred in the oxygen group (median, 8.0) than in the control group (median, 15.6; P = .016).
On average, the longest apnea-hypopnea event (median, 33.8 seconds) was shorter for a patient on oxygen, compared with a patient who did not receive oxygen (median, 49.6 seconds; P = .002).
But one finding surprised the researchers and led to some concern: Across both groups, 11.4% of patients experienced substantial CO2 retention. Specifically, for at least 10% of 1 of the nights, these patients had a partial pressure of CO2 of at least 55 mm Hg, according to measurements taken with a transcutaneous CO2 monitor. Of the 14 patients who experienced this event, 13 were receiving oxygen.
Dr. Chung said the results argue strongly for postsurgical oxygen in patients with OSA, who are known to be at increased risk for complications. “We are not doing something about it, and we should be doing something. Because one death from a complication is too many,” she said.
The study was funded by the University Health Network Foundation, Toronto, and the University of Toronto. Dr. Chung reported receiving research grant support from Ontario Ministry of Health Innovation Grant, University Health Network Foundation, ResMed Foundation, Acacia, and Medtronic.
Postoperative oxygen therapy in patients with previously undetected obstructive sleep apnea (OSA) led to a reduction in apnea-hypopnea index (AHI) events per hour with no increase in apnea-hypopnea event duration.
The results suggest that postoperative oxygen could be useful in patients with OSA who refuse continuous positive airway pressure (CPAP) therapy, those with newly diagnosed OSA, and those with suspected OSA.
The researchers set out to determine if postoperative oxygen therapy could improve oxygenation in patients with previously undiagnosed OSA, reasoning that the intervention could reduce adverse events.
The study, published in CHEST (2017 March;151[3]:597-611), provided generally good news, but with a caveat: “Essentially we are saying, yes, if you give supplemental oxygen, you improve oxygenation of the patient. But overall we have to be careful because a significant number of patients have significant carbon dioxide retention when receiving supplemental oxygen. So we have to monitor patients – not just oxygen, but we may have to monitor carbon dioxide levels, too,” said lead study author Frances Chung, MBBS, professor of anesthesiology at the University of Toronto and Toronto Western Hospital.
The researchers randomized 123 patients with an AHI of at least five events per hour to postoperative oxygen (3 L/min for 3 nights via nasal prongs) or no postoperative oxygen.
On the third night, the oxygen group had a higher average oxygen saturation than controls (95.2% plus or minus 3.2% vs. 91.4% plus or minus 3.5%; P less than .0001) and a lower oxygen desaturation index (median, 2.3 events per hour vs. median, 18.5; P less than .0001).
A lower number of AHI events per hour occurred in the oxygen group (median, 8.0) than in the control group (median, 15.6; P = .016).
On average, the longest apnea-hypopnea event (median, 33.8 seconds) was shorter for a patient on oxygen, compared with a patient who did not receive oxygen (median, 49.6 seconds; P = .002).
But one finding surprised the researchers and led to some concern: Across both groups, 11.4% of patients experienced substantial CO2 retention. Specifically, for at least 10% of 1 of the nights, these patients had a partial pressure of CO2 of at least 55 mm Hg, according to measurements taken with a transcutaneous CO2 monitor. Of the 14 patients who experienced this event, 13 were receiving oxygen.
Dr. Chung said the results argue strongly for postsurgical oxygen in patients with OSA, who are known to be at increased risk for complications. “We are not doing something about it, and we should be doing something. Because one death from a complication is too many,” she said.
The study was funded by the University Health Network Foundation, Toronto, and the University of Toronto. Dr. Chung reported receiving research grant support from Ontario Ministry of Health Innovation Grant, University Health Network Foundation, ResMed Foundation, Acacia, and Medtronic.
FROM CHEST
Key clinical point: Postsurgical oxygen may reduce complications in patients with obstructive sleep apnea.
Major finding: For patients receiving oxygen, the longest apnea-hypopnea event duration was 33.8 seconds versus 49.6 for controls.
Data source: A randomized, placebo-controlled study of 123 patients.
Disclosures: The study was funded by the University Health Network Foundation, Toronto, and the University of Toronto. Dr. Chung reported receiving research grant support from various entities.
Neoadjuvant chemoradiation may give transplant the edge over resection in biliary cancer
MIAMI BEACH – Survival for patients with hilar cholangiocarcinoma was similar between those who underwent transplantation and those who underwent resection, but neoadjuvant therapy may give transplant strategy the edge, findings of a study and meta-analysis suggest.
“Neoadjuvant chemoradiation therapy is clearly a factor that affects patient survival, and may be the only reason the patients who received transplantation had better overall survival than [did those who had] resection,” Michele Gage, MD, a general surgeon at Johns Hopkins Medicine in Baltimore, said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
“We found survival in the group that received neoadjuvant chemoradiation therapy and transplant had a statistically significantly better outcome compared to a control group of resection,” Dr. Gage said. More importantly, patients who received a transplant without neoadjuvant therapy had a statistically significant worse outcome than patients who got resection alone.”
The investigators noted that patient selection for neoadjuvant therapy might also be a factor contributing to superior overall survival. In a multicenter study of 147 patients undergoing liver transplantation for hilar cholangiocarcinoma, a subgroup of patients who met the selection criteria of the Mayo Clinic protocol but had not undergone neoadjuvant therapy had a 59% 5-year survival rate (PLoS One. 2016:11:e0156127).
Study discussant Maria B. Majella Doyle, MD, a general surgeon at Washington University in St. Louis, agreed that patient selection for transplantation is a likely factor.
Dr. Doyle then asked Dr. Gage how she accounts for the heterogeneity among studies performed over a 20-year period.
“That is why we did subgroup analysis of neoadjuvant versus no neoadjuvant therapy,” Dr. Gage replied.
In the future, an intent-to-treat analysis might be more accurate, Dr. Majella Doyle said, because more patients are placed on a liver transplant list than typically have the procedure.
Dr. Gage noted that 28%-48% of patients started on neoadjuvant therapy in the two studies that offered both neoadjuvant therapy and a transplant in the meta-analysis never made it to transplantation. When they were included, overall survival dropped to approximately 35% in one study and 44% in the other.
In the primary meta-analysis (before the subanalysis looking at neoadjuvant therapy), 398 patients underwent resection and another 200 underwent liver transplantation between 1996 and 2106. Patient demographics were similar between groups, including more men than women, except the average age in the resection group was older, Dr. Gage said.
Overall survival favored the transplant group at each time point: 78% versus 70% with resection at 1 year; 56% versus 42% at 3 years; and 46% versus 29% at 5 years. The odds ratios, respectively, were 1.27, 1.49 and 1.83, but the findings were not statistically significant at a 95% confidence interval.
Margin involvement was 9% in the transplant patients versus 32% in the resection patients, Dr. Gage said. The best chance of cure is R0 resection, but half of patients with hilar cholangiocarcinoma, the most common cancer of the biliary tract, are unresectable, she added.
Six of the nine studies in the meta-analysis reported margin status. Of the 344 patients in these studies, 79% achieved R0 status overall.
“The goal of treatment is R0 resection,” Dr. Gage said in response to a question about when neoadjuvant therapy is warranted. “In the patients who are resectable, I think the correct answer would be to proceed with resection. However, for those patients who are borderline resectable, it would be reasonable to consider neoadjuvant therapy.”
“One of the major things that is undervalued is neoadjuvant therapy allows better patient selection,” said session moderator Eric Jensen, MD, FACS, of University of Minnesota Health in Minneapolis. “When you say an obviously resectable tumor, when you look at the data – we’re wrong 30% of the time. So I’m in favor of neoadjuvant therapy for everybody, but that is just my bias.”
The small number of studies is a limitation of the study, Dr. Gage said. Also, all the studies were nonrandomized and retrospective, and some research spanned many years, which could introduce bias because of changes in practice over time, she added.
Based on their findings, the investigators proposed that future studies explore routine administration of neoadjuvant therapy prior to resection.
Dr. Gage and Dr. Majella Doyle had no relevant financial disclosures.
MIAMI BEACH – Survival for patients with hilar cholangiocarcinoma was similar between those who underwent transplantation and those who underwent resection, but neoadjuvant therapy may give transplant strategy the edge, findings of a study and meta-analysis suggest.
“Neoadjuvant chemoradiation therapy is clearly a factor that affects patient survival, and may be the only reason the patients who received transplantation had better overall survival than [did those who had] resection,” Michele Gage, MD, a general surgeon at Johns Hopkins Medicine in Baltimore, said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
“We found survival in the group that received neoadjuvant chemoradiation therapy and transplant had a statistically significantly better outcome compared to a control group of resection,” Dr. Gage said. More importantly, patients who received a transplant without neoadjuvant therapy had a statistically significant worse outcome than patients who got resection alone.”
The investigators noted that patient selection for neoadjuvant therapy might also be a factor contributing to superior overall survival. In a multicenter study of 147 patients undergoing liver transplantation for hilar cholangiocarcinoma, a subgroup of patients who met the selection criteria of the Mayo Clinic protocol but had not undergone neoadjuvant therapy had a 59% 5-year survival rate (PLoS One. 2016:11:e0156127).
Study discussant Maria B. Majella Doyle, MD, a general surgeon at Washington University in St. Louis, agreed that patient selection for transplantation is a likely factor.
Dr. Doyle then asked Dr. Gage how she accounts for the heterogeneity among studies performed over a 20-year period.
“That is why we did subgroup analysis of neoadjuvant versus no neoadjuvant therapy,” Dr. Gage replied.
In the future, an intent-to-treat analysis might be more accurate, Dr. Majella Doyle said, because more patients are placed on a liver transplant list than typically have the procedure.
Dr. Gage noted that 28%-48% of patients started on neoadjuvant therapy in the two studies that offered both neoadjuvant therapy and a transplant in the meta-analysis never made it to transplantation. When they were included, overall survival dropped to approximately 35% in one study and 44% in the other.
In the primary meta-analysis (before the subanalysis looking at neoadjuvant therapy), 398 patients underwent resection and another 200 underwent liver transplantation between 1996 and 2106. Patient demographics were similar between groups, including more men than women, except the average age in the resection group was older, Dr. Gage said.
Overall survival favored the transplant group at each time point: 78% versus 70% with resection at 1 year; 56% versus 42% at 3 years; and 46% versus 29% at 5 years. The odds ratios, respectively, were 1.27, 1.49 and 1.83, but the findings were not statistically significant at a 95% confidence interval.
Margin involvement was 9% in the transplant patients versus 32% in the resection patients, Dr. Gage said. The best chance of cure is R0 resection, but half of patients with hilar cholangiocarcinoma, the most common cancer of the biliary tract, are unresectable, she added.
Six of the nine studies in the meta-analysis reported margin status. Of the 344 patients in these studies, 79% achieved R0 status overall.
“The goal of treatment is R0 resection,” Dr. Gage said in response to a question about when neoadjuvant therapy is warranted. “In the patients who are resectable, I think the correct answer would be to proceed with resection. However, for those patients who are borderline resectable, it would be reasonable to consider neoadjuvant therapy.”
“One of the major things that is undervalued is neoadjuvant therapy allows better patient selection,” said session moderator Eric Jensen, MD, FACS, of University of Minnesota Health in Minneapolis. “When you say an obviously resectable tumor, when you look at the data – we’re wrong 30% of the time. So I’m in favor of neoadjuvant therapy for everybody, but that is just my bias.”
The small number of studies is a limitation of the study, Dr. Gage said. Also, all the studies were nonrandomized and retrospective, and some research spanned many years, which could introduce bias because of changes in practice over time, she added.
Based on their findings, the investigators proposed that future studies explore routine administration of neoadjuvant therapy prior to resection.
Dr. Gage and Dr. Majella Doyle had no relevant financial disclosures.
MIAMI BEACH – Survival for patients with hilar cholangiocarcinoma was similar between those who underwent transplantation and those who underwent resection, but neoadjuvant therapy may give transplant strategy the edge, findings of a study and meta-analysis suggest.
“Neoadjuvant chemoradiation therapy is clearly a factor that affects patient survival, and may be the only reason the patients who received transplantation had better overall survival than [did those who had] resection,” Michele Gage, MD, a general surgeon at Johns Hopkins Medicine in Baltimore, said at the annual meeting of the Americas Hepato-Pancreato-Biliary Association.
“We found survival in the group that received neoadjuvant chemoradiation therapy and transplant had a statistically significantly better outcome compared to a control group of resection,” Dr. Gage said. More importantly, patients who received a transplant without neoadjuvant therapy had a statistically significant worse outcome than patients who got resection alone.”
The investigators noted that patient selection for neoadjuvant therapy might also be a factor contributing to superior overall survival. In a multicenter study of 147 patients undergoing liver transplantation for hilar cholangiocarcinoma, a subgroup of patients who met the selection criteria of the Mayo Clinic protocol but had not undergone neoadjuvant therapy had a 59% 5-year survival rate (PLoS One. 2016:11:e0156127).
Study discussant Maria B. Majella Doyle, MD, a general surgeon at Washington University in St. Louis, agreed that patient selection for transplantation is a likely factor.
Dr. Doyle then asked Dr. Gage how she accounts for the heterogeneity among studies performed over a 20-year period.
“That is why we did subgroup analysis of neoadjuvant versus no neoadjuvant therapy,” Dr. Gage replied.
In the future, an intent-to-treat analysis might be more accurate, Dr. Majella Doyle said, because more patients are placed on a liver transplant list than typically have the procedure.
Dr. Gage noted that 28%-48% of patients started on neoadjuvant therapy in the two studies that offered both neoadjuvant therapy and a transplant in the meta-analysis never made it to transplantation. When they were included, overall survival dropped to approximately 35% in one study and 44% in the other.
In the primary meta-analysis (before the subanalysis looking at neoadjuvant therapy), 398 patients underwent resection and another 200 underwent liver transplantation between 1996 and 2106. Patient demographics were similar between groups, including more men than women, except the average age in the resection group was older, Dr. Gage said.
Overall survival favored the transplant group at each time point: 78% versus 70% with resection at 1 year; 56% versus 42% at 3 years; and 46% versus 29% at 5 years. The odds ratios, respectively, were 1.27, 1.49 and 1.83, but the findings were not statistically significant at a 95% confidence interval.
Margin involvement was 9% in the transplant patients versus 32% in the resection patients, Dr. Gage said. The best chance of cure is R0 resection, but half of patients with hilar cholangiocarcinoma, the most common cancer of the biliary tract, are unresectable, she added.
Six of the nine studies in the meta-analysis reported margin status. Of the 344 patients in these studies, 79% achieved R0 status overall.
“The goal of treatment is R0 resection,” Dr. Gage said in response to a question about when neoadjuvant therapy is warranted. “In the patients who are resectable, I think the correct answer would be to proceed with resection. However, for those patients who are borderline resectable, it would be reasonable to consider neoadjuvant therapy.”
“One of the major things that is undervalued is neoadjuvant therapy allows better patient selection,” said session moderator Eric Jensen, MD, FACS, of University of Minnesota Health in Minneapolis. “When you say an obviously resectable tumor, when you look at the data – we’re wrong 30% of the time. So I’m in favor of neoadjuvant therapy for everybody, but that is just my bias.”
The small number of studies is a limitation of the study, Dr. Gage said. Also, all the studies were nonrandomized and retrospective, and some research spanned many years, which could introduce bias because of changes in practice over time, she added.
Based on their findings, the investigators proposed that future studies explore routine administration of neoadjuvant therapy prior to resection.
Dr. Gage and Dr. Majella Doyle had no relevant financial disclosures.
AT AHPBA 2017
Nonoperative management of pediatric appendicitis appears feasible
Nonoperative management of uncomplicated acute appendicitis in the pediatric population appeared feasible and didn’t raise the risk of complications in the first metaanalysis to examine this approach, investigators reported March 27 in JAMA Pediatrics.
Nonoperative management, based on antibiotic treatment and close monitoring of the patient, is accepted as safe and effective in adults but has not been well studied in children and adolescents. “Owing to specific anatomical and pathophysiologic features of children, the clinical scenario of acute appendicitis in pediatric patients is different from that in adults, and treatment decisions for children are more difficult,” said Libin Huang, MD, of West China Hospital and Sichuan University, Chengdu, and his associates.
The few clinical trials that have been performed in children have had small sample sizes, so the investigators performed a meta-analysis to pool the results for 404 patients aged 5-18 years. They analyzed data from four single-center prospective but nonrandomized controlled trials and one single-center randomized controlled trial to compare outcomes between 168 patients initially treated with antibiotics and 236 who underwent immediate appendectomy.
Sixteen patients in the nonoperative group (9.5%) had treatment failure, defined as appendectomy within 48 hours (11 patients) or within 1 month of follow-up (5 patients). Three of these patients developed a complication (perforated appendicitis). In comparison, none of the surgery group had treatment failure, and one developed a complication requiring reoperation. Thus, the rate of success in the nonoperative group was 152 of 168 patients, or 90.5%, and the rate of complications was not significantly different between the two study groups, Dr. Huang and his associates said (JAMA Ped. 2017 Mar 27. doi: 10.1001/jamapediatrics.2017.0057).
During the following year, 27 patients in the nonoperative group had a histopathologically confirmed recurrence of appendicitis and underwent appendectomy; another 8 had the surgery because of parents’ requests. Nonoperative management was significantly more likely to fail in patients who had an appendicolith, so this approach should be considered inappropriate for this subgroup of patients, the investigators said.
Larger clinical trials with a randomized design, standardized criteria for antibiotic therapy, and longer follow-up are needed to confirm these preliminary findings, they added.
No sponsor was cited for this study. Dr. Huang and his associates reported having no relevant financial disclosures.
This is the first data synthesis on the effectiveness of nonoperative management compared with appendectomy in children, and it shows that the evidence at this time is simply insufficient to warrant a change in clinical practice. Appendectomy remains the standard of care for this disease.
Despite the high early “success rate” for nonoperative treatment, patients in this group were nearly nine times more likely to have “treatment failure” than those who underwent immediate appendectomy.
The nonoperative approach remains an experimental proposition and should be offered only under protocol in a clinical trial setting. It clearly merits ongoing consideration, but much more data from high-quality clinical trials are needed.
Monica E. Lopez, MD, and David E. Wesson, MD, are both with the division of pediatric surgery at Baylor College of Medicine and the department of surgery at Texas Children’s Hospital, both in Houston. They reported having no relevant financial disclosures. Dr. Lopez and Dr. Wesson made these remarks in an editorial accompanying Dr. Huang’s report (JAMA Ped. 2017 Mar 27. doi: 10.1001/jamapediatrics.2017.0056).
This is the first data synthesis on the effectiveness of nonoperative management compared with appendectomy in children, and it shows that the evidence at this time is simply insufficient to warrant a change in clinical practice. Appendectomy remains the standard of care for this disease.
Despite the high early “success rate” for nonoperative treatment, patients in this group were nearly nine times more likely to have “treatment failure” than those who underwent immediate appendectomy.
The nonoperative approach remains an experimental proposition and should be offered only under protocol in a clinical trial setting. It clearly merits ongoing consideration, but much more data from high-quality clinical trials are needed.
Monica E. Lopez, MD, and David E. Wesson, MD, are both with the division of pediatric surgery at Baylor College of Medicine and the department of surgery at Texas Children’s Hospital, both in Houston. They reported having no relevant financial disclosures. Dr. Lopez and Dr. Wesson made these remarks in an editorial accompanying Dr. Huang’s report (JAMA Ped. 2017 Mar 27. doi: 10.1001/jamapediatrics.2017.0056).
This is the first data synthesis on the effectiveness of nonoperative management compared with appendectomy in children, and it shows that the evidence at this time is simply insufficient to warrant a change in clinical practice. Appendectomy remains the standard of care for this disease.
Despite the high early “success rate” for nonoperative treatment, patients in this group were nearly nine times more likely to have “treatment failure” than those who underwent immediate appendectomy.
The nonoperative approach remains an experimental proposition and should be offered only under protocol in a clinical trial setting. It clearly merits ongoing consideration, but much more data from high-quality clinical trials are needed.
Monica E. Lopez, MD, and David E. Wesson, MD, are both with the division of pediatric surgery at Baylor College of Medicine and the department of surgery at Texas Children’s Hospital, both in Houston. They reported having no relevant financial disclosures. Dr. Lopez and Dr. Wesson made these remarks in an editorial accompanying Dr. Huang’s report (JAMA Ped. 2017 Mar 27. doi: 10.1001/jamapediatrics.2017.0056).
Nonoperative management of uncomplicated acute appendicitis in the pediatric population appeared feasible and didn’t raise the risk of complications in the first metaanalysis to examine this approach, investigators reported March 27 in JAMA Pediatrics.
Nonoperative management, based on antibiotic treatment and close monitoring of the patient, is accepted as safe and effective in adults but has not been well studied in children and adolescents. “Owing to specific anatomical and pathophysiologic features of children, the clinical scenario of acute appendicitis in pediatric patients is different from that in adults, and treatment decisions for children are more difficult,” said Libin Huang, MD, of West China Hospital and Sichuan University, Chengdu, and his associates.
The few clinical trials that have been performed in children have had small sample sizes, so the investigators performed a meta-analysis to pool the results for 404 patients aged 5-18 years. They analyzed data from four single-center prospective but nonrandomized controlled trials and one single-center randomized controlled trial to compare outcomes between 168 patients initially treated with antibiotics and 236 who underwent immediate appendectomy.
Sixteen patients in the nonoperative group (9.5%) had treatment failure, defined as appendectomy within 48 hours (11 patients) or within 1 month of follow-up (5 patients). Three of these patients developed a complication (perforated appendicitis). In comparison, none of the surgery group had treatment failure, and one developed a complication requiring reoperation. Thus, the rate of success in the nonoperative group was 152 of 168 patients, or 90.5%, and the rate of complications was not significantly different between the two study groups, Dr. Huang and his associates said (JAMA Ped. 2017 Mar 27. doi: 10.1001/jamapediatrics.2017.0057).
During the following year, 27 patients in the nonoperative group had a histopathologically confirmed recurrence of appendicitis and underwent appendectomy; another 8 had the surgery because of parents’ requests. Nonoperative management was significantly more likely to fail in patients who had an appendicolith, so this approach should be considered inappropriate for this subgroup of patients, the investigators said.
Larger clinical trials with a randomized design, standardized criteria for antibiotic therapy, and longer follow-up are needed to confirm these preliminary findings, they added.
No sponsor was cited for this study. Dr. Huang and his associates reported having no relevant financial disclosures.
Nonoperative management of uncomplicated acute appendicitis in the pediatric population appeared feasible and didn’t raise the risk of complications in the first metaanalysis to examine this approach, investigators reported March 27 in JAMA Pediatrics.
Nonoperative management, based on antibiotic treatment and close monitoring of the patient, is accepted as safe and effective in adults but has not been well studied in children and adolescents. “Owing to specific anatomical and pathophysiologic features of children, the clinical scenario of acute appendicitis in pediatric patients is different from that in adults, and treatment decisions for children are more difficult,” said Libin Huang, MD, of West China Hospital and Sichuan University, Chengdu, and his associates.
The few clinical trials that have been performed in children have had small sample sizes, so the investigators performed a meta-analysis to pool the results for 404 patients aged 5-18 years. They analyzed data from four single-center prospective but nonrandomized controlled trials and one single-center randomized controlled trial to compare outcomes between 168 patients initially treated with antibiotics and 236 who underwent immediate appendectomy.
Sixteen patients in the nonoperative group (9.5%) had treatment failure, defined as appendectomy within 48 hours (11 patients) or within 1 month of follow-up (5 patients). Three of these patients developed a complication (perforated appendicitis). In comparison, none of the surgery group had treatment failure, and one developed a complication requiring reoperation. Thus, the rate of success in the nonoperative group was 152 of 168 patients, or 90.5%, and the rate of complications was not significantly different between the two study groups, Dr. Huang and his associates said (JAMA Ped. 2017 Mar 27. doi: 10.1001/jamapediatrics.2017.0057).
During the following year, 27 patients in the nonoperative group had a histopathologically confirmed recurrence of appendicitis and underwent appendectomy; another 8 had the surgery because of parents’ requests. Nonoperative management was significantly more likely to fail in patients who had an appendicolith, so this approach should be considered inappropriate for this subgroup of patients, the investigators said.
Larger clinical trials with a randomized design, standardized criteria for antibiotic therapy, and longer follow-up are needed to confirm these preliminary findings, they added.
No sponsor was cited for this study. Dr. Huang and his associates reported having no relevant financial disclosures.
FROM JAMA PEDIATRICS
Key clinical point: Nonoperative management of uncomplicated appendicitis in the pediatric population appeared feasible and didn’t raise the risk of complications in the first metaanalysis to examine this approach.
Major finding: The rate of treatment success in the nonoperative group was 90.5% (152 of 168 patients).
Data source: A metaanalysis of five single-center clinical trials involving 404 patients aged 5-18 years.
Disclosures: No sponsor was cited for this study. Dr. Huang and his associates reported having no relevant financial disclosures.
Gradual increase of nonoperative management of selected abdominal gunshot wounds
Selective nonoperative management of abdominal gunshot wounds has progressed from heresy a few years ago to established practice now, at least at Level I and Level II trauma centers across New England, according to a report published online in the Journal of the American College of Surgeons.
“Mandatory laparotomy used to be the only acceptable standard of care” for this patient population, but many surgeons now realize that a hole in the abdomen doesn’t necessitate immediate laparotomy. “Patients with a reliable clinical exam, who are hemodynamically stable and without signs of peritonitis, can be observed under structured protocols of close monitoring, frequent clinical exams, and appropriate imaging,” said Thomas Peponis, MD, of Massachusetts General Hospital, Boston, and his associates.
Two findings belie the main arguments that opponents of SNOM have made in favor of routine laparotomy: delaying surgery leads to devastating consequences and “unnecessary” laparotomies are virtually harmless.
The first finding was that the 18 patients in the SNOM group (1.9% of the entire study population) who eventually required a delayed laparotomy had few postoperative complications, and none of the complications appeared to be directly related to the delay in surgery. Those SNOM patients who eventually had surgery did not differ in terms of age, sex, location of the gunshot wound, vitals on ED presentation, Glasgow Coma Scale on ED presentation, presence of hemodynamic instability, or presence of diffuse abdominal tenderness on clinical exam.
The second finding concerned the 104 patients who underwent immediate exploratory laparotomy. Dr. Peponis and his associates deemed the immediacy to be nontherapeutic (unnecessary) because “the mere presence of a hole to the abdomen was the only indication” for the surgery. Nearly one in six patients operated on for an abdominal gunshot wound underwent a nontherapeutic laparotomy. Of those, 18 (17.3%) developed postoperative complications, including wound infections, ileus, pneumonia, pleural effusion requiring a chest tube, intra-abdominal abscess, acute kidney injury, sepsis, venous embolus, and a fistula related to a retained bullet.
The rate of abdominal gunshot wounds treated nonoperatively in the centers studied has grown from around 18% before 2010 to 27% in the following years. The increasing use of CT scans has bolstered the trend, but the clinical exam remains the critical element in deciding whether to operate immediately. The investigators recommended immediate surgery for all abdominal gunshot wound patients who are hemodynamically unstable or who exhibit diffuse abdominal tenderness. “There is no other place for a patient with an abdominal gunshot wound and definitively worsening clinical symptoms than the OR. The remaining patients are appropriate for SNOM under close observation, repeat clinical evaluations, and immediate OR availability in case the clinical picture changes.”
The limitations of the study are the following: First, it represents only Level I and II centers with experienced trauma teams. Second, there is no commonly established protocol across trauma centers for SNOM, giving rise to a variability in decision making and care. Third, the definition of immediate and delayed surgery was within a 2-hour window, a somewhat arbitrary time period.
The investigation was sponsored by the Research Consortium of New England Centers for Trauma (ReCoNECT). The authors had no disclosures.
Selective nonoperative management of abdominal gunshot wounds has progressed from heresy a few years ago to established practice now, at least at Level I and Level II trauma centers across New England, according to a report published online in the Journal of the American College of Surgeons.
“Mandatory laparotomy used to be the only acceptable standard of care” for this patient population, but many surgeons now realize that a hole in the abdomen doesn’t necessitate immediate laparotomy. “Patients with a reliable clinical exam, who are hemodynamically stable and without signs of peritonitis, can be observed under structured protocols of close monitoring, frequent clinical exams, and appropriate imaging,” said Thomas Peponis, MD, of Massachusetts General Hospital, Boston, and his associates.
Two findings belie the main arguments that opponents of SNOM have made in favor of routine laparotomy: delaying surgery leads to devastating consequences and “unnecessary” laparotomies are virtually harmless.
The first finding was that the 18 patients in the SNOM group (1.9% of the entire study population) who eventually required a delayed laparotomy had few postoperative complications, and none of the complications appeared to be directly related to the delay in surgery. Those SNOM patients who eventually had surgery did not differ in terms of age, sex, location of the gunshot wound, vitals on ED presentation, Glasgow Coma Scale on ED presentation, presence of hemodynamic instability, or presence of diffuse abdominal tenderness on clinical exam.
The second finding concerned the 104 patients who underwent immediate exploratory laparotomy. Dr. Peponis and his associates deemed the immediacy to be nontherapeutic (unnecessary) because “the mere presence of a hole to the abdomen was the only indication” for the surgery. Nearly one in six patients operated on for an abdominal gunshot wound underwent a nontherapeutic laparotomy. Of those, 18 (17.3%) developed postoperative complications, including wound infections, ileus, pneumonia, pleural effusion requiring a chest tube, intra-abdominal abscess, acute kidney injury, sepsis, venous embolus, and a fistula related to a retained bullet.
The rate of abdominal gunshot wounds treated nonoperatively in the centers studied has grown from around 18% before 2010 to 27% in the following years. The increasing use of CT scans has bolstered the trend, but the clinical exam remains the critical element in deciding whether to operate immediately. The investigators recommended immediate surgery for all abdominal gunshot wound patients who are hemodynamically unstable or who exhibit diffuse abdominal tenderness. “There is no other place for a patient with an abdominal gunshot wound and definitively worsening clinical symptoms than the OR. The remaining patients are appropriate for SNOM under close observation, repeat clinical evaluations, and immediate OR availability in case the clinical picture changes.”
The limitations of the study are the following: First, it represents only Level I and II centers with experienced trauma teams. Second, there is no commonly established protocol across trauma centers for SNOM, giving rise to a variability in decision making and care. Third, the definition of immediate and delayed surgery was within a 2-hour window, a somewhat arbitrary time period.
The investigation was sponsored by the Research Consortium of New England Centers for Trauma (ReCoNECT). The authors had no disclosures.
Selective nonoperative management of abdominal gunshot wounds has progressed from heresy a few years ago to established practice now, at least at Level I and Level II trauma centers across New England, according to a report published online in the Journal of the American College of Surgeons.
“Mandatory laparotomy used to be the only acceptable standard of care” for this patient population, but many surgeons now realize that a hole in the abdomen doesn’t necessitate immediate laparotomy. “Patients with a reliable clinical exam, who are hemodynamically stable and without signs of peritonitis, can be observed under structured protocols of close monitoring, frequent clinical exams, and appropriate imaging,” said Thomas Peponis, MD, of Massachusetts General Hospital, Boston, and his associates.
Two findings belie the main arguments that opponents of SNOM have made in favor of routine laparotomy: delaying surgery leads to devastating consequences and “unnecessary” laparotomies are virtually harmless.
The first finding was that the 18 patients in the SNOM group (1.9% of the entire study population) who eventually required a delayed laparotomy had few postoperative complications, and none of the complications appeared to be directly related to the delay in surgery. Those SNOM patients who eventually had surgery did not differ in terms of age, sex, location of the gunshot wound, vitals on ED presentation, Glasgow Coma Scale on ED presentation, presence of hemodynamic instability, or presence of diffuse abdominal tenderness on clinical exam.
The second finding concerned the 104 patients who underwent immediate exploratory laparotomy. Dr. Peponis and his associates deemed the immediacy to be nontherapeutic (unnecessary) because “the mere presence of a hole to the abdomen was the only indication” for the surgery. Nearly one in six patients operated on for an abdominal gunshot wound underwent a nontherapeutic laparotomy. Of those, 18 (17.3%) developed postoperative complications, including wound infections, ileus, pneumonia, pleural effusion requiring a chest tube, intra-abdominal abscess, acute kidney injury, sepsis, venous embolus, and a fistula related to a retained bullet.
The rate of abdominal gunshot wounds treated nonoperatively in the centers studied has grown from around 18% before 2010 to 27% in the following years. The increasing use of CT scans has bolstered the trend, but the clinical exam remains the critical element in deciding whether to operate immediately. The investigators recommended immediate surgery for all abdominal gunshot wound patients who are hemodynamically unstable or who exhibit diffuse abdominal tenderness. “There is no other place for a patient with an abdominal gunshot wound and definitively worsening clinical symptoms than the OR. The remaining patients are appropriate for SNOM under close observation, repeat clinical evaluations, and immediate OR availability in case the clinical picture changes.”
The limitations of the study are the following: First, it represents only Level I and II centers with experienced trauma teams. Second, there is no commonly established protocol across trauma centers for SNOM, giving rise to a variability in decision making and care. Third, the definition of immediate and delayed surgery was within a 2-hour window, a somewhat arbitrary time period.
The investigation was sponsored by the Research Consortium of New England Centers for Trauma (ReCoNECT). The authors had no disclosures.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS
Key clinical point: Selective nonoperative management of abdominal gunshot wounds has progressed from heresy a few years ago to established practice now.
Major finding: 197 patients (91.6% of the nonoperative group and 21.4% of the entire study population) were successfully managed nonoperatively and were discharged without requiring any abdominal surgery.
Data source: A retrospective review of the medical records of 922 gunshot wound patients treated at 10 New England trauma centers during a 20-year period.
Disclosures: The investigation was a multicenter study of the Research Consortium of New England Centers for Trauma (ReCoNECT). Dr. Peponis and his associates reported having no relevant financial disclosures.
AGA Clinical Practice Update: Using FLIP to assess upper GI tract still murky territory
New clinical practice advice has been issued for use of the functional lumen imaging probe (FLIP) to assess disorders of the upper gastrointestinal tract, with the main takeaway being the device’s potency in diagnosing achalasia.
“Although the strongest data appear to be focused on the management of achalasia, emerging evidence supports the clinical relevance of FLIP in the assessment of disease severity and as an outcome measure in [eosinophilic esophagitis (EoE)] intervention trials,” wrote the authors of the update, led by John E. Pandolfino, MD, of Northwestern University, Chicago. The report is in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.
10.022).
In terms of evaluating the LES, however, FLIP can be used during laparoscopic Heller myotomy or peroral endoscopic myotomy (POEM) as a way of monitoring the LES. Using FLIP this way can help clinicians and surgeons personalize the procedure to each patient, even while it’s ongoing. FLIP also can be used with dilation balloons, with the balloon diameter allowing dilation measurement without the need to also use fluoroscopy.
For treating gastroesophageal reflux disease (GERD), the evidence found in existing literature points with less certainty toward use of FLIP.
“The role of FLIP for physiologic evaluation and management in GERD remains appealing; however, the level of evidence is low and currently FLIP should not be used in routine GERD management,” the authors explained. “Future outcome studies are needed to substantiate the utility of FLIP in GERD and to develop metrics that predict severity and treatment response after antireflux procedures.”
FLIP can be used in managing eosinophilic esophagitis, but is recommended only in certain scenarios. According to the authors, FLIP can be used to measure esophageal narrowing and the overall esophageal body. FLIP also can be used to measure esophageal distensibility, and, in the case of at least one study reviewed by the authors, allows “significantly greater accuracy and precision in estimating the effects of remodeling” in certain patients.
Dr. Pandolfino and his colleagues warned that “current recommendations are limited by the low level of evidence and lack of generalized availability of the analysis paradigms.” They noted the need for “further outcome studies that validate the distensibility plateau threshold and further refinements in software analyses to make this methodology more generalizable.”
Overall, the authors concluded, more study still needs to be done to ascertain exactly what FLIP is capable of and when it can be used to greatest effect. In addition to evaluating its benefit in patients with GERD, research should focus on how to make data obtained via FLIP easier to interpret and put to use.
“More work is needed [that] focuses on optimizing data analysis, standardizing protocols, and defining outcome metrics prior to the widespread adoption [of FLIP] into general clinical practice,” the authors wrote.
Dr. Pandolfino disclosed relationships with Medtronic and Sandhill Scientific. Other coauthors did not report any relevant financial disclosures.
*This story updated on 3/9/2017.
New clinical practice advice has been issued for use of the functional lumen imaging probe (FLIP) to assess disorders of the upper gastrointestinal tract, with the main takeaway being the device’s potency in diagnosing achalasia.
“Although the strongest data appear to be focused on the management of achalasia, emerging evidence supports the clinical relevance of FLIP in the assessment of disease severity and as an outcome measure in [eosinophilic esophagitis (EoE)] intervention trials,” wrote the authors of the update, led by John E. Pandolfino, MD, of Northwestern University, Chicago. The report is in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.
10.022).
In terms of evaluating the LES, however, FLIP can be used during laparoscopic Heller myotomy or peroral endoscopic myotomy (POEM) as a way of monitoring the LES. Using FLIP this way can help clinicians and surgeons personalize the procedure to each patient, even while it’s ongoing. FLIP also can be used with dilation balloons, with the balloon diameter allowing dilation measurement without the need to also use fluoroscopy.
For treating gastroesophageal reflux disease (GERD), the evidence found in existing literature points with less certainty toward use of FLIP.
“The role of FLIP for physiologic evaluation and management in GERD remains appealing; however, the level of evidence is low and currently FLIP should not be used in routine GERD management,” the authors explained. “Future outcome studies are needed to substantiate the utility of FLIP in GERD and to develop metrics that predict severity and treatment response after antireflux procedures.”
FLIP can be used in managing eosinophilic esophagitis, but is recommended only in certain scenarios. According to the authors, FLIP can be used to measure esophageal narrowing and the overall esophageal body. FLIP also can be used to measure esophageal distensibility, and, in the case of at least one study reviewed by the authors, allows “significantly greater accuracy and precision in estimating the effects of remodeling” in certain patients.
Dr. Pandolfino and his colleagues warned that “current recommendations are limited by the low level of evidence and lack of generalized availability of the analysis paradigms.” They noted the need for “further outcome studies that validate the distensibility plateau threshold and further refinements in software analyses to make this methodology more generalizable.”
Overall, the authors concluded, more study still needs to be done to ascertain exactly what FLIP is capable of and when it can be used to greatest effect. In addition to evaluating its benefit in patients with GERD, research should focus on how to make data obtained via FLIP easier to interpret and put to use.
“More work is needed [that] focuses on optimizing data analysis, standardizing protocols, and defining outcome metrics prior to the widespread adoption [of FLIP] into general clinical practice,” the authors wrote.
Dr. Pandolfino disclosed relationships with Medtronic and Sandhill Scientific. Other coauthors did not report any relevant financial disclosures.
*This story updated on 3/9/2017.
New clinical practice advice has been issued for use of the functional lumen imaging probe (FLIP) to assess disorders of the upper gastrointestinal tract, with the main takeaway being the device’s potency in diagnosing achalasia.
“Although the strongest data appear to be focused on the management of achalasia, emerging evidence supports the clinical relevance of FLIP in the assessment of disease severity and as an outcome measure in [eosinophilic esophagitis (EoE)] intervention trials,” wrote the authors of the update, led by John E. Pandolfino, MD, of Northwestern University, Chicago. The report is in the March issue of Clinical Gastroenterology and Hepatology (doi: 10.1016/j.cgh.2016.
10.022).
In terms of evaluating the LES, however, FLIP can be used during laparoscopic Heller myotomy or peroral endoscopic myotomy (POEM) as a way of monitoring the LES. Using FLIP this way can help clinicians and surgeons personalize the procedure to each patient, even while it’s ongoing. FLIP also can be used with dilation balloons, with the balloon diameter allowing dilation measurement without the need to also use fluoroscopy.
For treating gastroesophageal reflux disease (GERD), the evidence found in existing literature points with less certainty toward use of FLIP.
“The role of FLIP for physiologic evaluation and management in GERD remains appealing; however, the level of evidence is low and currently FLIP should not be used in routine GERD management,” the authors explained. “Future outcome studies are needed to substantiate the utility of FLIP in GERD and to develop metrics that predict severity and treatment response after antireflux procedures.”
FLIP can be used in managing eosinophilic esophagitis, but is recommended only in certain scenarios. According to the authors, FLIP can be used to measure esophageal narrowing and the overall esophageal body. FLIP also can be used to measure esophageal distensibility, and, in the case of at least one study reviewed by the authors, allows “significantly greater accuracy and precision in estimating the effects of remodeling” in certain patients.
Dr. Pandolfino and his colleagues warned that “current recommendations are limited by the low level of evidence and lack of generalized availability of the analysis paradigms.” They noted the need for “further outcome studies that validate the distensibility plateau threshold and further refinements in software analyses to make this methodology more generalizable.”
Overall, the authors concluded, more study still needs to be done to ascertain exactly what FLIP is capable of and when it can be used to greatest effect. In addition to evaluating its benefit in patients with GERD, research should focus on how to make data obtained via FLIP easier to interpret and put to use.
“More work is needed [that] focuses on optimizing data analysis, standardizing protocols, and defining outcome metrics prior to the widespread adoption [of FLIP] into general clinical practice,” the authors wrote.
Dr. Pandolfino disclosed relationships with Medtronic and Sandhill Scientific. Other coauthors did not report any relevant financial disclosures.
*This story updated on 3/9/2017.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Monofilament suture works best for cesarean closure
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler
LAS VEGAS – A monofilament suture led to substantially fewer wound complications than a braided suture for closing nonemergency cesarean incisions in a head-to-head trial with 520 evaluable women.
Cesarean incision closure with a braided, polyglactin 910 suture (Vicryl) led to 65% more wound complications than the monofilament poliglecaprone 25 suture (Monocryl), Arin M. Buresch, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
This is the first randomized, controlled trial to compare these two suture types, according to Dr. Buresch, and she highlighted the need for caution about changing practice based on results from a single study. But based in large part on these results, which were gathered at Montefiore Medical Center in New York, the obstetrical staff at Montefiore is now primarily using the monofilament, poliglecaprone 25 suture, she said.
The study enrolled 550 pregnant women at 37 weeks’ gestation or greater during May 2015 to July 2016. Participants were either scheduled for an elective cesarean delivery or underwent a nonemergency, indicated cesarean after labor began but without significant maternal or fetal distress. The study excluded emergency cesareans as well as women with a recent urogenital infection, chronic or injected steroid use, or a vertical skin incision. The enrolled women averaged 31 years old, and their average body mass index was 34 kg/m2. The demographic and clinical profile of the two randomized groups closely matched.
The study’s primary endpoint was the incidence of a wound complication during 30 days following delivery. A complication could be a surgical site infection, hematoma, seroma, or wound separation. Of the 550 women randomized, 520 were available for complete 30-day follow-up.
The results showed that wound complications occurred in 9% of the 263 women treated with the poliglecaprone 25 monofilament suture and in 14% of the 257 treated with the polyglactin 910 braided suture, a statistically significant difference, Dr. Buresch reported. The relative risk for a complication increased by 65% with the braided suture, compared with patients treated with monofilament sutures. Treating 18 patients with the monofilament suture prevented one wound complication, on average.
A subgroup analysis showed that the poliglecaprone 25 suture was effective at reducing wound complications in women who underwent elective cesarean deliveries, but among the 17% of participants who had begun labor at the time of their cesarean delivery the monofilament suture conferred no significant advantage, compared with the braided suture. Benefit from the poliglecaprone 25 monofilament occurred about equally across the entire range of body mass index among the women in the study, Dr. Buresch said.
Dr. Buresch had no disclosures.
[email protected]
On Twitter @mitchelzoler