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Investigators busy with other projects at the moment.
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Surgical resection is the only option for cure for patients with a resectable tumor located at the head of the pancreas. At the time of diagnosis, these patients often suffer from jaundice. Studies have suggested, that jaundice might increase the risk of developing a serious postoperative complication. Preoperative biliary drainage is widely used, because it is considered to improve the surgical outcome and reduce the amount of postoperative complications. There are also studies that suggest the opposite. In these studies the overall complication rate with patients who underwent preoperative biliary drainage was higher than in the patients who were operated right away. A significant amount of these complications were related to the biliary drainage process itself. However, preoperative biliary decompression is widely used in many centers as many surgical centers don't possess the needed resources to arrange early surgery. The benefits and risks of this procedure remain unclear. This multicenter trial aims to compare the surgical outcome and the rate of serious complications in patients who proceed directly to early surgery and patients who have preoperative biliary drainage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early surgery | No Intervention | Patients in this group proceed to pancreatic resection within 2 week of recruitment. | |
| Preoperative biliary drainage | Active Comparator | Endoscopic retrograde cholangiopancreatography (ERCP) is used to place an endoprosthesis to the biliary ducts to drain biliary stasis, and the patients proceed to pancreatic resection within 6 weeks of recruitment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tannenbaum Fr 10 stent or WallFlex stent | Device | A plastic or metallic endoprosthesis is placed to the biliary ducts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Emerged complications related to surgery or preoperative endoscopy within 120 days of surgery | 120 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sini Vehviläinen, MD | Helsinki University Central Hospital | Study Chair |
| Hanna Seppänen, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Arto Kokkola, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Marianne Udd, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Outi Lindström, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Johanna Louhimo, MD, PhD | Helsinki University Central Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | Uusimaa | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18726134 | Background | van der Gaag NA, Kloek JJ, de Castro SM, Busch OR, van Gulik TM, Gouma DJ. Preoperative biliary drainage in patients with obstructive jaundice: history and current status. J Gastrointest Surg. 2009 Apr;13(4):814-20. doi: 10.1007/s11605-008-0618-4. Epub 2008 Aug 23. | |
| 20071702 | Background | van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |