Clinical trial · Interventional
Covered Versus Uncovered Biliary Stents for Biliary Malignancies
Covered Versus Uncovered Metal Stents for Biliary Malignancies - A Randomized Controlled Trial
NCT02102984CI-TRIAL-00021548completedN/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)
Patency duration of covered metal stents as compared with uncovered metal stents in the management of malignant strictures of the extra-hepatic biliary tree.
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 Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| covered biliary stents | Device | — | UNRESOLVED |
| uncovered biliary stents | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- covered stents
- description
- endoscopic placement of covered biliary stents
- interventionNames
- Device: covered biliary stents
- type
- ACTIVE_COMPARATOR
- label
- uncovered biliary stents
- description
- endoscopic placement of uncovered biliary stents
- interventionNames
- Device: uncovered biliary stents
Primary outcomes (1)
- measure
- Relief of malignant biliary obstruction
- timeFrame
- six months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adult patients with symptomatic malignant obstruction of the extra-hepatic biliary tree * not eligible for surgical intervention * able to provide informed consent Exclusion Criteria: * benign biliary obstruction * previous surgery of the biliary tract * life expectancy \< 3 months
References
Publications (2)
- BACKGROUNDIsayama H, Nakai Y, Kogure H, Yamamoto N, Koike K. Biliary self-expandable metallic stent for unresectable malignant distal biliary obstruction: which is better: covered or uncovered? Dig Endosc. 2013 May;25 Suppl 2:71-4. doi: 10.1111/den.12078. PMID 23617653
- DERIVEDConio M, Mangiavillano B, Caruso A, Filiberti RA, Baron TH, De Luca L, Signorelli S, Crespi M, Marini M, Ravelli P, Conigliaro R, De Ceglie A. Covered versus uncovered self-expandable metal stent for palliation of primary malignant extrahepatic biliary strictures: a randomized multicenter study. Gastrointest Endosc. 2018 Aug;88(2):283-291.e3. doi: 10.1016/j.gie.2018.03.029. Epub 2018 Apr 11. PMID 29653120