A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures (Wallstent)
|Inoperable Tumors of the Bile Duct||Device: Partially Covered Wallstent Device: Uncovered Wallstent|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Supportive Care
|Official Title:||A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures|
- Time to Recurrent Biliary Obstruction [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]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.
- Patient Survival [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]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.
- Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: From time of stent placement to participant death or lost to follow-up (up to 1302 days) ]Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.
- Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism [ Time Frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm ]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.
|Actual Study Start Date:||October 2002|
|Study Completion Date:||November 2009|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Uncovered Wallstent
Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
Device: Uncovered Wallstent
Experimental: Partially Covered Wallstent
Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
Device: Partially Covered Wallstent
Partially covered wallstent
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047332
|Principal Investigator:||David L Carr-Locke, MD, FRCP||Brigham and Women's Hospital|