Endoscopic Stenting Across the Papilla Versus the Leak Site to Treat Bile Leak
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|