Clinical trial · Interventional
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)
A Prospective, Randomized, Single Blind Study to Evaluate the Effectiveness and Safety Comparing Niti-S Mira-Cover III Biliary Stent With ComVi Biliary Covered Stent in Patients With Malignant Biliary Obstruction
NCT02460432CI-TRIAL-00026917completedN/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 effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.
Conditions
Conditions (3)
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 Neoplasms | — | UNRESOLVED | — |
| Biliary Obstruction | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Covered Metal Stent | Device | — | UNRESOLVED |
| Paclitaxel-eluting metal Stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paclitaxel-eluting metal Stent
- description
- Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea)
- interventionNames
- Device: Paclitaxel-eluting metal Stent
- type
- ACTIVE_COMPARATOR
- label
- Covered Metal Stent
- description
- ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea)
- interventionNames
- Device: Covered Metal Stent
Primary outcomes (1)
- measure
- Cumulative stent patency during 6months after stent placement
- timeFrame
- 6 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Age greater than or equal to 19 years of age * Malignant mid or distal biliary obstruction * Unresectable cancer * Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60) * Patient willing to provide written informed consent and comply with follow-up requirements Exclusion Criteria: * Patients who had undergone surgical biliary drainage * Severe bleeding disorder (e.g. coagulopathy) * Polypoid lesion or intra-abdominal abscess * Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
References
Publications (1)
- DERIVEDJang SI, Lee KT, Choi JS, Jeong S, Lee DH, Kim YT, Lee SH, Yu JS, Lee DK. Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study. Endoscopy. 2019 Sep;51(9):843-851. doi: 10.1055/a-0754-5763. Epub 2018 Nov 9. PMID 30414164