Clinical trial · Interventional
Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction
Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
NCT02255669CI-TRIAL-00016852unknownN/AClinicalTrials.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 duration of stent patency between partially covered and fully covered SEMS for palliation of 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 |
|---|---|---|---|
| Biliary Tract Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fully covered SEMS | Device | — | UNRESOLVED |
| partially covered SEMS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- partially covered SEMS
- description
- Deployment of Partially covered biliary self expandable metal stent
- interventionNames
- Device: partially covered SEMS
- type
- ACTIVE_COMPARATOR
- label
- fully covered SEMS
- description
- Deployment of Fully covered biliary self expandable metal stent
- interventionNames
- Device: fully covered SEMS
Primary outcomes (1)
- measure
- duration of stent patency
- timeFrame
- From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 1.\> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal Exclusion Criteria: * 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR\>1.5, Platelet\<50000) 4.expected survival \> 3 months based on Karnofsky performance score 5.duodenal stricture
References
Publications (0)
Data not yet available
No reference posted for this study.