Clinical trial · Interventional
Covered vs. Uncovered SEMS for Occluded Biliary Metal Stents
Re-intervention for Occluded Biliary Metal Stent in Malignant Distal Bile Duct Obstruction: a Prospective Randomized Multi-center Trial Comparing Covered and Uncovered Metal Stent
- 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)
Endoscopic retrograde biliary drainage (ERBD) is now widely accepted as the standard intervention for the relief of obstructive jaundice in patients with unresectable malignant biliary obstruction. Although plastic stents (PSs) were developed earlier, self-expandable metal stents (SEMSs) are now used widely as the initial choice for ERBD in this setting, as SEMSs offer longer patency.However, SEMSs do become occluded in some patients. There are a limited number of reports on the management of occluded SEMS with various results. The aim of this study is to compare the efficacy of ComVi stents SEMSs with uncovered SEMS in subsequent ERBD after the occlusion of initial SEMSs.
Conditions
Conditions (2)
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 | — |
| Jaundice, Obstructive | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ComVi stent | Device | — | UNRESOLVED |
| Uncovered SEMS | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ComVi stent
- description
- ComVi stent (Niti-S stent, ComVi type, Taewoong Medical Inc, Korea)
- interventionNames
- Device: ComVi stent
- type
- ACTIVE_COMPARATOR
- label
- Uncovered SEMS
- description
- uncovered nitinol metal stent (HANAROSTENT, M.I. Tech Co., Ltd., Korea)
- interventionNames
- Device: Uncovered SEMS
Primary outcomes (1)
- measure
- The stent patency
- timeFrame
- up to 53 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with SEMS occlusion, which was inserted either endoscopically or percutaneously, for the relief of malignant nonhilar biliary obstruction * Patients in whom the above SEMS had been inserted for no less than 7 days * Patients with one of the following: 1. cholangitis (as defined by fever, tenderness in the right upper quadrant or epigastrium, and/or a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion) 2. a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion * Patients in whom the cause of initial ERBD occlusion was identified, such as tumor overgrowth, ingrowth, and/or sludge * Age ≥ 20 years Exclusion Criteria: * Unable to give informed consent * Patients with sepsis and/or shock not responding to medical treatment or Eastern Cooperative Oncology Group (ECOG) Performance Status 4 * Patients with estimated survival \< 4 weeks * Patients who had undergone curative or palliative surgical intervention * Hilar or perihilar biliary obstruction * Patients who had undergone endoscopic nasobiliary drainage,plastic stent insertion, or percutaneous transhepatic biliary drainage prior to second SEMS insertion * Covered SEMS as initial SEMS * Migration or food impaction as the cause of initial SEMS occlusion
References
Publications (1)
- DERIVEDLee BS, Ryu JK, Jang DK, Chung KH, Yoon WJ, Kim J, Woo SM, Lee SH, Lee WJ, Kim YT. Reintervention for occluded metal stent in malignant bile duct obstruction: A prospective randomized trial comparing covered and uncovered metal stent. J Gastroenterol Hepatol. 2016 Nov;31(11):1901-1907. doi: 10.1111/jgh.13392. PMID 27029890