Clinical trial · Interventional
Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Investigators busy with other projects at the moment
Summary
Brief summary (as posted)
This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded. This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Self-expandable metallic biliary stent | Device | — | UNRESOLVED |
| Tannenbaum 10 Fr biliary stent | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Plastic biliary stent
- description
- A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression
- interventionNames
- Device: Tannenbaum 10 Fr biliary stent
- type
- EXPERIMENTAL
- label
- Self-expandable metallic biliary stent
- description
- A self-expandable metallic biliary stent is used to achieve biliary decompression
- interventionNames
- Device: Self-expandable metallic biliary stent
Primary outcomes (1)
- measure
- Stent failure rate, and need for re-procedure before pancreaticoduodenectomy.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Resectable tumor of the head of the pancreas * Elevated serum bilirubin levels * Radiologically visible dilatation of the biliary system Exclusion Criteria: * Distant metastasis * Inoperable tumor or other reason, why the patient is unfit for surgery
References
Publications (3)
- BACKGROUNDDecker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4. PMID 21373939
- BACKGROUNDHaapamaki C, Seppanen H, Udd M, Juuti A, Halttunen J, Kiviluoto T, Siren J, Mustonen H, Kylanpaa L. Preoperative biliary decompression preceding pancreaticoduodenectomy with plastic or self-expandable metallic stent. Scand J Surg. 2015 Jun;104(2):79-85. doi: 10.1177/1457496914543975. Epub 2014 Jul 15. PMID 25028410
- BACKGROUNDVelanovich V, Kheibek T, Khan M. Relationship of postoperative complications from preoperative biliary stents after pancreaticoduodenectomy. A new cohort analysis and meta-analysis of modern studies. JOP. 2009 Jan 8;10(1):24-9. PMID 19129611