Preoperative biliary drainage for pancreato-biliary tumors causing obstructive jaundice; DRainage vs Operation.
- Conditions
- Obstructive jaundice due to a pancreatic head area (pancreas, papilla, distal bile duct) tumor.
- Registration Number
- NL-OMON20283
- Brief Summary
Incidence and management of pancreatic leakage after pancreatoduodenectomy. de Castro SM, Busch OR, van Gulik TM, Obertop H, Gouma DJ. Br J Surg. 2005 Sep;92(9):1117-23. <br> Delayed massive hemorrhage after pancreatic and biliary surgery: embolization or surgery? de Castro SM, Kuhlmann KF, Busch OR, van Delden OM, Lameris JS, van Gulik TM, Obertop H, Gouma DJ. Ann Surg. 2005 Jan;241(1):85-91. <br> Recurrent disease after microscopically radical (R0) resection of periampullary adenocarcinoma in patients without adjuvant therapy. de Castro SM, Kuhlmann KF, van Heek NT, Busch OR, Offerhaus GJ, van Gulik TM, Obertop H, Gouma DJ. J Gastrointest Surg. 2004 Nov;8(7):775-84; discussion 784. <br> Surgical management of neoplasms of the ampulla of Vater: local resection or pancreatoduodenectomy and prognostic factors for survival. de Castro SM, van Heek NT, Kuhlmann KF, Busch OR, Offerhaus GJ, van Gulik TM, Obertop H, Gouma DJ. Surgery. 2004 Nov;136(5):994-1002 <br> Management of bleeding and leakage after pancreatic surgery. de Castro SM, Busch OR, Gouma DJ. Best Pract Res Clin Gastroenterol. 2004 Oct;18(5):847-64.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 210
1. Clinical diagnosis of obstructive jaundice due to a pancreatic head or periampullary tumor;
2. A serum bilirubin level of > 40 µmol/l and < 250 µmol/l at randomization;
1. Age > 85 years or severe co-morbidity (Karnofsky <50%) and other contra indications for major surgery;
2. Cholangitis/infection;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with severe complications due to drainage or postoperative within 120 days after randomisation (90 days after surgery).
- Secondary Outcome Measures
Name Time Method 1. Hospital stay;<br><br />2. Number of extra invasive diagnostic procedures;<br><br />3. Costs;<br><br />4. Quality of Life;<br><br />5. Analysis of CT criteria for resectability.