Clinical trial · Interventional
Efficacy of Partial Covered Double Bare Metal Stent Compared to Uncovered Double Bare Metal Stent in Malignant Biliary Obstruction
Efficacy of Partial Covered Double Bare Metal Stent Compared to Uncovered Double Bare Metal Stent in Malignant Biliary Obstruction: A Multicenter Prospective Randomized Trial
- 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)
Previous studies indicated that covered stents are less likely to become occluded in comparison to bare stents. While the probability of occlusions caused by tumor in-growth is less in covered stents, they are more likely to spontaneously migrate to a position that is distal to the original deployment site. However, newer covered stents with improved designs, such as the partially covered double bare metallic stent used for this study, include features to mitigate the migration issue. The purpose of this study is to confirm whether the difference in patency rate between regular covered stents and bare stents, which has already been well established by existing studies, is also reproducible when double covered stents are compared against double bare stents.
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 |
|---|---|---|---|
| Malignant Tumor | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SEMS(self-expandable metallic stent) | Device | — | UNRESOLVED |
| Stenting by ERCP (endoscopic retrograde cholangiopancreatography) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- the intervention group
- description
- Partial covered double bare metal stent
- interventionNames
- Device: SEMS(self-expandable metallic stent)
- type
- ACTIVE_COMPARATOR
- label
- the control group
- description
- Uncovered double bare metal stent
- interventionNames
- Device: Stenting by ERCP (endoscopic retrograde cholangiopancreatography)
Primary outcomes (1)
- measure
- Mean duration of stent patency
- timeFrame
- 6 months after stenting
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed malignant biliary obstruction or clinically defined malignant biliary obstruction * malignant biliary obstruction was located more than 1cm from the hilum * older than 20 years old * Life expectancy \> 6 months * Inoperable case due to advanced stage or comorbidity * Informed consent obtained Exclusion Criteria: * Inadequate case for ERCP * Failed endoscopic approach to duodenum or biliary tract * biliary obstruction was located at hilum or IHD * patients with uncontrolled infection * Pregnancy * No signed informed consent
References
Publications (1)
- DERIVEDPark SW, Lee KJ, Chung MJ, Jo JH, Lee HS, Park JY, Park SW, Song SY, Kang H, Kim EJ, Kim YS, Cho JH, Bang S. Covered versus uncovered double bare self-expandable metal stent for palliation of unresectable extrahepatic malignant biliary obstruction: a randomized controlled multicenter trial. Gastrointest Endosc. 2023 Jan;97(1):132-142.e2. doi: 10.1016/j.gie.2022.08.041. Epub 2022 Sep 7. PMID 36084714