Clinical trial · Interventional
A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
NCT01047332CI-TRIAL-00026904WallstentcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Inoperable Tumors of the Bile Duct | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partially Covered Wallstent | Device | — | UNRESOLVED |
| Uncovered Wallstent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Uncovered Wallstent
- description
- Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
- interventionNames
- Device: Uncovered Wallstent
- type
- EXPERIMENTAL
- label
- Partially Covered Wallstent
- description
- Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
- interventionNames
- Device: Partially Covered Wallstent
Primary outcomes (1)
- measure
- Time to Recurrent Biliary Obstruction
- timeFrame
- Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTTelford 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. PMID 21034891