Clinical trial · Interventional
Covered vs Uncovered Metal Stents for Palliative Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
Randomized Controlled Trial Comparing Covered Versus Uncovered Metal Stents for Biliary Decompression in Inoperable Malignant Distal Bile Duct Obstruction
NCT01905384CI-TRIAL-00057431completedN/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 this study is to compare the rate of long-term stent failure, defined as need for repeat biliary intervention following placement of C-SEMS vs U-SEMS for palliation of inoperable malignant distal bile duct obstruction.
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 |
|---|---|---|---|
| Distal Bile Duct Obstruction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Covered Self-expanding metal biliary stents (C-SEMS) | Device | — | UNRESOLVED |
| Uncovered Self-expanding metal biliary stents (U-SEMS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- U-SEMS group
- description
- Patients undergoing routine care ERCP and randomized to 10 mm diameter Uncovered Self-expanding metal biliary stents (U-SEMS) (Wallflex, Boston Scientific).
- interventionNames
- Device: Uncovered Self-expanding metal biliary stents (U-SEMS)
- type
- ACTIVE_COMPARATOR
- label
- C-SEMS Group
- description
- Patients undergoing routine care ERCP and randomized to a 10 mm diameter Covered Self-Expanding metal biliary stents (C-SEMS) (Wallflex, Boston Scientific)
- interventionNames
- Device: Covered Self-expanding metal biliary stents (C-SEMS)
Primary outcomes (1)
- measure
- Rate of Long-term Stent Failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * distal bile obstruction referred for ERCP with intended palliative metal stent placement for palliation of jaundice * 18 years of age or older * serum bilirubin \> 2mg/dL Exclusion Criteria: * prior endoscopic or percutaneous biliary drainage * post-surgical anatomy * primary site of biliary obstruction involving the common hepatic duct or hilum * tumor involving gastric outlet, duodenum, or ampulla either precluding endoscopic access to the papilla or otherwise preventing endoscopic biliary cannulation
References
Publications (0)
Data not yet available
No reference posted for this study.