Endoscopic Stenting Across the Papilla Versus the Leak Site to Treat Bile Leak

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03103139
Recruitment Status : Enrolling by invitation
First Posted : April 6, 2017
Last Update Posted : February 14, 2018
Information provided by (Responsible Party):
James Buxbaum, University of Southern California

Brief Summary:
  1. Biliary duct injury are a relatively frequent complication of hepatobiliary surgery, most comonly laparoscopic cholecystecomy.
  2. Prior to the development of more sophisticated endoscopic interventions, repeat surgery was often necessary for the management of biliary leaks.
  3. Advances in technique and technology in gastroenterology endoscopy have largely replaced surgery as the first line intervention for biliary leak.
  4. Most practices utilize endoscopic plastic biliary stent placement alone and are efficacious and equivalent to the biliary stent placement with endoscopic biliary sphincterotomy.
  5. 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).
  6. 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing ERCP for the treatment of suspected acute bile leaks will be eligible for inclusion (bile leaks felt to be complications of surgical intervention). A patient is suspected to have an acute bile leak if the patient is referred within two weeks following the original surgery.. Legally authorized representatives may serve as surrogates to consent for inclusion in this study.

Bile leaks are suspected based on the following:

A) Persistent, significant drainage of bilious fluid from post-surgical drains following hepatobiliary surgery or cholecystectomy,.

B) Compatible symptoms plus imaging findings on abdominal ultrasonography, computed tomography, HIDA scanning, or MRCP of an abnormal intra-abdominal fluid collection in the setting of recent hepatobiliary surgery.

Exclusion Criteria:

  • Patients with bile duct transection (in which the duct has been totally severed into 2 parts) will be excluded as these are known to not be amenable to endoscopic therapy. Further, suspected bile leaks of non-surgical etiology will be excluded from the study (malignancy, trauma, spontaneous perforation, and other rarer causes). Bile leaks suspected two weeks post surgery will also not be included. Additionally patients who are pregnant, imprisoned, under age 18, unable to give informed consent, or have undergone prior biliary diversion surgery will be excluded.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03103139

United States, California
Los Angeles County Hospital
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: James Buxbaum, M.D. USC Health Sciences Center

Publications of Results:

Responsible Party: James Buxbaum, Associate Professor, University of Southern California Identifier: NCT03103139     History of Changes
Other Study ID Numbers: HS-16-00520
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No