Bile Leak Clinical Trial
Official title:
Randomized Controlled Trial Of Endoscopic Stenting Across the Papilla Versus the Leak Site to Treat Bile Leak
Verified date | September 2023 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 92 |
Est. completion date | October 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Los Angeles County Hospital | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients with resolution of bile leak by cholangiography | The primary outcome is the proportion of patients with resolution of bile leak determined by cholangiography at 5 weeks among the two groups. | within 5 weeks | |
Secondary | Time to from ERCP to remove surgical drain | The time from the ERCP to removal of surgical drain will be compared in the two groups. | within 5 weeks | |
Secondary | Proportion of patients who required surgery | The proportion of patients who require surgery the manage the bile leaks in the two groups were compared. | within 10 weeks |
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