N/A
N=129
A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
Inoperable Tumors of the Bile Duct
Bottom Line
View on ClinicalTrials.gov: NCT01047332 ↗Enrolled (actual)
129
Serious AEs
53.5%
Results posted
Apr 2017
Primary outcome: Primary: Time to Recurrent Biliary Obstruction — 711; 357 days — p=0.530
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Partially Covered Wallstent (Device); Uncovered Wallstent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Recurrent Biliary Obstruction |
711; 357 | 0.530 |
| SECONDARY Patient Survival |
239; 227 | 0.997 |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs) |
27; 42 | — |
| SECONDARY Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism |
8; 6; 0; 3; 0; 6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01047332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.