Clinical trial · Interventional
Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent
A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.
NCT01413386CI-TRIAL-00043946MIRAIIterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Delayed subject enrollment
Summary
Brief summary (as posted)
Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.
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 Stricture | — | UNRESOLVED | — |
| Malignant Neoplasms | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biliary stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paclitaxel Eluting Covered Metal Stent
- interventionNames
- Device: biliary stent
- type
- ACTIVE_COMPARATOR
- label
- Covered Metal Stent
- interventionNames
- Device: biliary stent
Primary outcomes (1)
- measure
- Accumulative Patency Rate
- timeFrame
- 6 months
Secondary outcomes (3)
- measure
- Accumulative Survival Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patient who submitted a written informed consent for the this trial, and 18 \~ 90 years old * Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion * Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis * Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly * Patient who have life expectancy at least longer than 3 months (Karnofsky score \>60%) Exclusion Criteria: * Patient who previously had surgical biliary drainage * Patient who carrying bleeding disorder * Patient who have combined Hilar and/or intra-hepatic duct cancer * Patient who is improper to endoscopic treatment
References
Publications (0)
Data not yet available
No reference posted for this study.