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Investigators busy with other projects at the moment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plastic biliary stent | Experimental | A plastic (ie Tannenbaum 10 Fr) biliary stent is used to achieve biliary decompression |
|
| Self-expandable metallic biliary stent | Experimental | A self-expandable metallic biliary stent is used to achieve biliary decompression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tannenbaum 10 Fr biliary stent | Device | Tannenbaum 10 Fr biliary stent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Stent failure rate, and need for re-procedure before pancreaticoduodenectomy. | Evaluation at the day of pancreatic surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Other complications related to preoperative biliary decompression, and post-surgical complications | Complication emerged within 120 days from pancreaticoduodenectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leena Kylänpää, MD, PhD | Helsinki University Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Uusimaa | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21373939 | Background | 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. | |
| 25028410 | Background | Haapamaki 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. |
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| Self-expandable metallic biliary stent |
| Device |
ie WallFlex biliary RX |
|
| 19129611 | Background | 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. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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