- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01047332
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Uncovered Wallstent
Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
|
Uncovered wallstent
|
Experimental: Partially Covered Wallstent
Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
|
Partially covered wallstent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
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)
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.
|
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
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.
|
Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David L Carr-Locke, MD, FRCP, Brigham and Women's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BS-816
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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