Overview

This trial is active, not recruiting.

Condition inoperable tumors of the bile duct
Treatments wallstent, non-covered wallstent
Sponsor Brigham and Women's Hospital
Collaborator Boston Scientific Corporation
Start date August 2002
End date November 2009
Trial size 276 participants
Trial identifier NCT01047332, BS-816

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
wallstent
Covered wallstent
(Active Comparator)
non-covered wallstent
non-covered wallstent

Primary Outcomes

Measure
To compare the stent patency time in the uncovered and covered Wallstent groups in subjects with malignant bile duct strictures.
time frame: 3 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - greater than 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.

Additional Information

Official title A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
Principal investigator David L Carr-Locke, MD, FRCP
Trial information was received from ClinicalTrials.gov and was last updated in January 2010.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.