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

Mass General Brigham

Status: Completed

Conditions: Inoperable Tumors of the Bile Duct

Treatments: Device: Partially Covered Wallstent; Device: Uncovered Wallstent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01047332

BS-816

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 129 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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129 participants in 2 patient groups

Uncovered Wallstent

Active Comparator group

Description:

Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).

Treatment:

Device: Uncovered Wallstent

Partially Covered Wallstent

Experimental group

Description:

Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).

Treatment:

Device: Partially Covered Wallstent