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

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

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.

Study Overview

• Status: Completed
• Conditions: Inoperable Tumors of the Bile Duct
• Intervention / Treatment: Device: Uncovered Wallstent; Device: Partially Covered Wallstent

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: David L Carr-Locke, MD, FRCP, Brigham and Women's Hospital

Publications and helpful links

General Publications

• Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, Schapiro RH, Huang CS, Lichtenstein DR, Jacobson BC, Saltzman JR, Thompson CC, Forcione DG, Gostout CJ, Brugge WR. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc. 2010 Nov;72(5):907-14. doi: 10.1016/j.gie.2010.08.021.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2002
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 12, 2010

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: BS-816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO