Clinical trial · Interventional
Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression
A Randomized Trial Comparing Covered Metal and Plastic Stents for Preoperative Biliary Decompression in Pancreatic Cancer
- 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)
Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.
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 |
|---|---|---|---|
| Metal stent | Procedure | — | UNRESOLVED |
| Plastic stent | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Metal stent
- description
- Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
- interventionNames
- Procedure: Metal stent
- type
- ACTIVE_COMPARATOR
- label
- Plastic Stent
- description
- Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a plastic stent
- interventionNames
- Procedure: Plastic stent
Primary outcomes (1)
- measure
- Complications related to stent dysfunction
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with pancreatic cancer and mass in the head of pancreas causing jaundice. * Patients 19 yrs of age and older * Serum bilirubin \> 2mg/dl * 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: * Karnofsky score \< 60 * Prior (ERCP or PTC) attempts at biliary decompression for the same indication * Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day) * Ongoing or planned neoadjuvant therapy * Cholangitis at presentation or coagulopathy needing reversal medication * Post-surgical anatomy * Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum * Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
References
Publications (0)
Data not yet available