Clinical trial · Interventional
Trial Comparing Metal Versus Plastic Stents for Preoperative Biliary Decompression
Multicenter Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
NCT01675908CI-TRIAL-00056872completedN/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)
Compare the performance of full covered metal stents and plastic stents for preoperative biliary decompression
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 |
|---|---|---|---|
| Obstructive Jaundice | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Complications | Procedure | — | UNRESOLVED |
| Stent Dysfunction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metal stent
- description
- Patients randomized to one cohort will undergo placement of fully covered self expandable metal stents. The rates (%) of stent dysfunction and complications will be evaluated.
- interventionNames
- Procedure: Stent Dysfunction
- Procedure: Complications
- type
- ACTIVE_COMPARATOR
- label
- Plastic Stent
- description
- At ERCP, a 10Fr plastic stent will be placed in the bile duct. The rates (%) of stent dysfunction and complications will be evaluated.
- interventionNames
- Procedure: Stent Dysfunction
- Procedure: Complications
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
INCLUSION CRITERIA: 1. Patients with pancreatic cancer and mass in the head of pancreas causing jaundice. 2. Patients 19 yrs of age and older 3. Serum bilirubin \> 2mg/dl 4. CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin). EXCLUSION CRITERIA: 1. Karnofsky score \< 60 2. Prior (ERCP or PTC) attempts at biliary decompression for the same indication 3. Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day) 4. Ongoing or planned neoadjuvant therapy 5. Cholangitis at presentation or coagulopathy needing reversal medication 6. Post-surgical anatomy 7. Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum 8. Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
References
Publications (0)
Data not yet available
No reference posted for this study.