Clinical trial · Interventional
Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.
Prospective Evaluation of Luminal Patency of a Prototype Large Plastic Biliary Stent in the Palliation of Malignant Distal Biliary Strictures.
NCT01590394CI-TRIAL-00029929terminatedN/AResults postedClinicalTrials.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): Difficulty in enrolling subjects and transporting scope for sterilization
Summary
Brief summary (as posted)
Plastic biliary stents which are a new larger size will remain free of obstructions for a longer period of time than currently used 10 French stents in cancer in the common bile duct.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Obstruction | — | UNRESOLVED | — |
| Stricture | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Large plastic biliary stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pancreatic Cancer Patients
- description
- A large plastic biliary stent was placed in the bile duct.
- interventionNames
- Device: Large plastic biliary stent
Primary outcomes (1)
- measure
- Large Plastic Biliary Stents Will Have a Longer Patency Time Than Conventionally Used 10 Fr Stents in Subjects as Compared to Well-known Published Historical Control Data.
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion Criteria: 1. ≥ 18 and ≤ 85 years of age 2. Malignant biliary obstruction, known or suspected 3. Increased bilirubin or jaundice or history thereof 4. Duct stricture (obstruction) ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts) 5. Not an operative candidate Exclusion Criteria: 1. Unable to obtain consent 2. Unable to tolerate endoscopic procedure 3. Suspected non-malignant bile duct stricture 4. Candidate for potentially curative surgical intervention 5. Previous SEMS 6. Previous bile duct surgery 7. Diffuse liver metastasis 8. Peritoneal metastasis by CT 9. Presence of ascites 10. Duodenal obstruction preventing passage of the duodenoscope to the level of the papilla 11. Failure to cannulate bile duct during ERCP 12. Karnofsky performance score \< 40
References
Publications (0)
Data not yet available
No reference posted for this study.