Endoscopic Stenting Across the Papilla Versus the Leak Site to Treat Bile Leak
|ClinicalTrials.gov Identifier: NCT03103139|
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2017
Last Update Posted : February 14, 2018
- Biliary duct injury are a relatively frequent complication of hepatobiliary surgery, most comonly laparoscopic cholecystecomy.
- Prior to the development of more sophisticated endoscopic interventions, repeat surgery was often necessary for the management of biliary leaks.
- Advances in technique and technology in gastroenterology endoscopy have largely replaced surgery as the first line intervention for biliary leak.
- Most practices utilize endoscopic plastic biliary stent placement alone and are efficacious and equivalent to the biliary stent placement with endoscopic biliary sphincterotomy.
- An area of variation is in whether biliary stent should cross the papilla ( with a shorter stent) versus the site of the bile leak (with a longer stent).
- Our objective is to assess whether placing a biliary stent across the leak versus across the papilla alone improves the treatment of biliary leaks.
|Condition or disease||Intervention/treatment||Phase|
|Bile Leak||Procedure: Transpapillary Stent Procedure: Stent across bile leak||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trial Of Endoscopic Stenting Across the Papilla Versus the Leak Site to Treat Bile Leak|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Active Comparator: Transpapillary Stents
Stent placement across the Papilla (with a short plastic stent) for biliary leak
Procedure: Transpapillary Stent
ERCP with placement of short stent
Experimental: Stent across bile leak
Stent placement across the bile leak (with a longer stent) for biliary leak
Procedure: Stent across bile leak
ERCP with long stent
- Proportion of patients with resolution of bile leak by cholangiography [ Time Frame: within 5 weeks ]The primary outcome is the proportion of patients with resolution of bile leak determined by cholangiography at 5 weeks among the two groups.
- Time to from ERCP to remove surgical drain [ Time Frame: within 5 weeks ]The time from the ERCP to removal of surgical drain will be compared in the two groups.
- Proportion of patients who required surgery [ Time Frame: within 10 weeks ]The proportion of patients who require surgery the manage the bile leaks in the two groups were compared.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103139
|United States, California|
|Los Angeles County Hospital|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||James Buxbaum, M.D.||USC Health Sciences Center|