A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

Study Overview
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Brief Summary
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The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.

Detailed Description
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This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota). Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.

Official Title
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A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

Conditions
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Inoperable Tumors of the Bile Duct

Intervention / Treatment
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* Device: Partially Covered Wallstent
* Device: Uncovered Wallstent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age. Malignant bile duct stricture. Increased bilirubin. Duct stricture is ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts). Not an operative candidate. Exclusion Criteria: Unable to obtain consent. Unable to tolerate procedure. Suspected benign bile duct stricture. Candidate for potentially curative surgical intervention. Previous metallic biliary stent. Previous bile duct surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Uncovered Wallstent<br>Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). | Device: Uncovered Wallstent<br>* Uncovered wallstent<br>|
| Experimental: Partially Covered Wallstent<br>Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). | Device: Partially Covered Wallstent<br>* Partially covered wallstent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Recurrent Biliary Obstruction | Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death. | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Survival | Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview. | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm | 
| Number of Participants With Serious Adverse Events (SAEs) | Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death. | From time of stent placement to participant death or lost to follow-up (up to 1302 days) | 
| Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism | Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group. | Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm |