Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Plastic biliary stent A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression |
Device: Tannenbaum 10 Fr biliary stent
Tannenbaum 10 Fr biliary stent
|
| Experimental: Self-expandable metallic biliary stent A self-expandable metallic biliary stent is used to achieve biliary decompression |
Device: Self-expandable metallic biliary stent
ie WallFlex biliary RX
|
Outcome Measures
Primary Outcome Measures
- Stent failure rate, and need for re-procedure before pancreaticoduodenectomy. [Evaluation at the day of pancreatic surgery]
Secondary Outcome Measures
- Other complications related to preoperative biliary decompression, and post-surgical complications [Complication emerged within 120 days from pancreaticoduodenectomy]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Helsinki University Hospital | Helsinki | Uusimaa | Finland | 00029 |
Sponsors and Collaborators
- Helsinki University Central Hospital
Investigators
- Principal Investigator: Leena Kylänpää, MD, PhD, Helsinki University Central Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Decker 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.
- Haapamäki C, Seppänen H, Udd M, Juuti A, Halttunen J, Kiviluoto T, Sirén J, Mustonen H, Kylänpää 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.
- Velanovich 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.
- HUS/2470/2017