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ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.
Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.
"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.
Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.
To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.
The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.
But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.
In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).
Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.
The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.
*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.
For patients with unresectable pancreatic cancer, self-expandable metallic stents (SEMS) are preferred to smaller-caliber, plastic stents for the palliation of jaundice. SEMS have longer patency rates and reduce the overall costs of care by obviating the need for stent exchanges in the majority of cases. Further, SEMS have largely replaced surgical bypass of the bile duct because of reduced morbidity and acceptable durability since most patients with unresectable pancreatic cancer are not expected to survive more than 1 year.
The decision to place a SEMS with complete or partial coating, primarily designed to reduce the likelihood of tumor ingrowth within the interstices of the stent, is more complex. Coating reduces ingrowth and modestly prolongs patency, but increases the likelihood of stent migration and possibly cholecystitis (due to occlusion of the cystic duct). Presumably due to their larger diameter than plastic stents, previous studies suggested a higher rate of post-ERCP (post-endoscopic retrograde cholangiopancreatography) pancreatitis, irrespective of preexisting endoscopic sphincterotomy.
 |
| Dr. Gregory Cote |
Second, pancreatitis rates of 8%-9% are higher than expected for a low-risk indication such as malignant bile duct obstruction. The higher rates in this trial may be related to study design (patients in clinical trials are expected to have higher event rates due to meticulous follow-up compared with retrospective studies), use of SEMS in all patients, and specificity of the definition of post-ERCP pancreatitis in this population: Patients with pancreatic cancer are more likely to complain of pain following ERCP that is related to expansion of the metal stent, and a rise in serum pancreatic enzymes that may not necessarily connote true acute pancreatitis. This requires further investigation.
Third, bleeding and perforation are uncommon complications of ERCP with or without sphincterotomy when a high-volume physician performs the procedure. These data corroborate this - the argument that skipping the sphincterotomy will lower an already rare set of events is challenging. In fact, the only observed perforation occurred in a patient randomized to no sphincterotomy! Last, the higher rates (albeit not statistically significant) of hepatic abscess and cholecystitis among patients who did not undergo a sphincterotomy should not be ignored.
In some cases, sphincterotomy facilitates passage of the stent delivery catheter and tissue sampling devices, if needed. Nevertheless, endoscopists should be reassured by the equivalent rates of pancreatitis in this clinical trial. Based on these results, it seems appropriate to withhold sphincterotomy, at least in cases where bleeding may be high risk (e.g., with ongoing use of antiplatelet or anticoagulant medications).
Dr. Gregory A. Cote is an assistant professor of medicine in the department of medicine, division of gastroenterology and hepatology, Indiana University School of Medicine, Indianapolis. He is a consultant and member of the advisory board for Boston Scientific and a member of the advisory board for Olympus America.
For patients with unresectable pancreatic cancer, self-expandable metallic stents (SEMS) are preferred to smaller-caliber, plastic stents for the palliation of jaundice. SEMS have longer patency rates and reduce the overall costs of care by obviating the need for stent exchanges in the majority of cases. Further, SEMS have largely replaced surgical bypass of the bile duct because of reduced morbidity and acceptable durability since most patients with unresectable pancreatic cancer are not expected to survive more than 1 year.
The decision to place a SEMS with complete or partial coating, primarily designed to reduce the likelihood of tumor ingrowth within the interstices of the stent, is more complex. Coating reduces ingrowth and modestly prolongs patency, but increases the likelihood of stent migration and possibly cholecystitis (due to occlusion of the cystic duct). Presumably due to their larger diameter than plastic stents, previous studies suggested a higher rate of post-ERCP (post-endoscopic retrograde cholangiopancreatography) pancreatitis, irrespective of preexisting endoscopic sphincterotomy.
|
| Dr. Gregory Cote |
Second, pancreatitis rates of 8%-9% are higher than expected for a low-risk indication such as malignant bile duct obstruction. The higher rates in this trial may be related to study design (patients in clinical trials are expected to have higher event rates due to meticulous follow-up compared with retrospective studies), use of SEMS in all patients, and specificity of the definition of post-ERCP pancreatitis in this population: Patients with pancreatic cancer are more likely to complain of pain following ERCP that is related to expansion of the metal stent, and a rise in serum pancreatic enzymes that may not necessarily connote true acute pancreatitis. This requires further investigation.
Third, bleeding and perforation are uncommon complications of ERCP with or without sphincterotomy when a high-volume physician performs the procedure. These data corroborate this - the argument that skipping the sphincterotomy will lower an already rare set of events is challenging. In fact, the only observed perforation occurred in a patient randomized to no sphincterotomy! Last, the higher rates (albeit not statistically significant) of hepatic abscess and cholecystitis among patients who did not undergo a sphincterotomy should not be ignored.
In some cases, sphincterotomy facilitates passage of the stent delivery catheter and tissue sampling devices, if needed. Nevertheless, endoscopists should be reassured by the equivalent rates of pancreatitis in this clinical trial. Based on these results, it seems appropriate to withhold sphincterotomy, at least in cases where bleeding may be high risk (e.g., with ongoing use of antiplatelet or anticoagulant medications).
Dr. Gregory A. Cote is an assistant professor of medicine in the department of medicine, division of gastroenterology and hepatology, Indiana University School of Medicine, Indianapolis. He is a consultant and member of the advisory board for Boston Scientific and a member of the advisory board for Olympus America.
For patients with unresectable pancreatic cancer, self-expandable metallic stents (SEMS) are preferred to smaller-caliber, plastic stents for the palliation of jaundice. SEMS have longer patency rates and reduce the overall costs of care by obviating the need for stent exchanges in the majority of cases. Further, SEMS have largely replaced surgical bypass of the bile duct because of reduced morbidity and acceptable durability since most patients with unresectable pancreatic cancer are not expected to survive more than 1 year.
The decision to place a SEMS with complete or partial coating, primarily designed to reduce the likelihood of tumor ingrowth within the interstices of the stent, is more complex. Coating reduces ingrowth and modestly prolongs patency, but increases the likelihood of stent migration and possibly cholecystitis (due to occlusion of the cystic duct). Presumably due to their larger diameter than plastic stents, previous studies suggested a higher rate of post-ERCP (post-endoscopic retrograde cholangiopancreatography) pancreatitis, irrespective of preexisting endoscopic sphincterotomy.
|
| Dr. Gregory Cote |
Second, pancreatitis rates of 8%-9% are higher than expected for a low-risk indication such as malignant bile duct obstruction. The higher rates in this trial may be related to study design (patients in clinical trials are expected to have higher event rates due to meticulous follow-up compared with retrospective studies), use of SEMS in all patients, and specificity of the definition of post-ERCP pancreatitis in this population: Patients with pancreatic cancer are more likely to complain of pain following ERCP that is related to expansion of the metal stent, and a rise in serum pancreatic enzymes that may not necessarily connote true acute pancreatitis. This requires further investigation.
Third, bleeding and perforation are uncommon complications of ERCP with or without sphincterotomy when a high-volume physician performs the procedure. These data corroborate this - the argument that skipping the sphincterotomy will lower an already rare set of events is challenging. In fact, the only observed perforation occurred in a patient randomized to no sphincterotomy! Last, the higher rates (albeit not statistically significant) of hepatic abscess and cholecystitis among patients who did not undergo a sphincterotomy should not be ignored.
In some cases, sphincterotomy facilitates passage of the stent delivery catheter and tissue sampling devices, if needed. Nevertheless, endoscopists should be reassured by the equivalent rates of pancreatitis in this clinical trial. Based on these results, it seems appropriate to withhold sphincterotomy, at least in cases where bleeding may be high risk (e.g., with ongoing use of antiplatelet or anticoagulant medications).
Dr. Gregory A. Cote is an assistant professor of medicine in the department of medicine, division of gastroenterology and hepatology, Indiana University School of Medicine, Indianapolis. He is a consultant and member of the advisory board for Boston Scientific and a member of the advisory board for Olympus America.
ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.
Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.
"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.
Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.
To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.
The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.
But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.
In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).
Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.
The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.
*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.
ORLANDO – Patients with unresectable pancreatic cancer may be safely spared from endoscopic sphincterotomy prior to stent placement, investigators said at the annual Digestive Disease Week.
Among patients undergoing placement of a self-expanding, 10-mm-diameter stent into the bile duct*, there were no differences in the rates of early or late complications between patients randomized to receive endoscopic sphincterotomy (ES) before stent placement and those who underwent stent placement alone, reported Dr. Tsuyoshi Hayashi from Sapporo Medical University in Japan.
"ES had no effect on not only the incidence of complications but also SEMS [self-expanding metal stent] patency and patient survival. ES is an unnecessary pretreatment prior to SEMS placement for distal biliary obstruction due to pancreatic cancer," Dr. Hayashi said.
Although endoscopic sphincterotomy is intended to prevent potential pancreatitis from the expansion forces of the stent on the opening of the pancreatic duct, it adds significantly to operative time and carries the risk of bleeding or perforation, Dr. Hayashi said.
To see whether the endoscopist could safely forego sphincterotomy, investigators in 25 hospitals on Japan’s northern island of Hokkaido enrolled a total of 200 patients into a randomized trial and assigned them to stent placement with or without sphincterotomy. Four patients assigned to sphincterotomy and two assigned to stenting alone were unable to undergo biliary cannulation, leaving 96 and 98 patients, respectively, for the analysis.
The authors found that sphincterotomy added significantly to the procedural time, at a mean of 577 (plus or minus 310) seconds, compared with 388 (plus or minus 203) seconds for the no-sphincterotomy procedures.
But when they looked at early complications (within 30 days of the procedure), they found that there were no significant between-group differences in the rates of mild to severe pancreatitis, moderate bleeding, mild perforation, moderate hepatic abscess, pain, or vomiting.
In addition, there were no significant between-group differences in late complications, including either mild to severe cholecystitis, pancreatitis, bleeding, or duodenal ulcer. Similarly, there were no significant differences between the sphincterotomy group and the no-sphincterotomy group in either median time to stent dysfunction (170.5 vs. 148.0 days, respectively) or median overall survival (242 vs. 202 days).
Causes of stent dysfunction, which occurred in 25 patients in each group, included food impaction, sludge formation, intestinal obstruction, migration, and tumor ingrowth or overgrowth, but there were no significant between-group differences in the causes.
The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.
*Correction 7/25/2013: An earlier version of this story missnamed this duct and stent.
AT DDW 2013
Major finding: There were no significant differences in early or late complications among patients with pancreatic cancer who underwent stent placement with or without sphincterotomy.
Data source: Randomized controlled trial in 200 patients from 25 treatment centers in Japan,
Disclosures: The study funding source was not disclosed. Dr. Hayashi and his colleagues reported having no financial disclosures.