Preoperative biliary drainage with metal stent.

Recruiting

Conditions: periampullary cancer, jaundice, pancreas tumor

Registration Number: NL-OMON26508

Lead Sponsor: Academic Medical Center (AMC)

Brief Summary: Preoperative biliary drainage for cancer of the head of the pancreas. 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. N Engl J Med. 2010 Jan 14;362(2):129-37. Therapeutic delay and survival after surgery for cancer of the pancreatic head with or without preoperative biliary drainage. Eshuis WJ, van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, Kuipers EJ, Coene PP, 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. Ann Surg. 2010 Nov;252(5):840-9. Preoperative biliary drainage in patients with obstructive jaundice: history and current status. van der Gaag NA, Kloek JJ, de Castro SM, Busch OR, van Gulik TM, Gouma DJ. J Gastrointest Surg. 2009 Apr;13(4):814-20. Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial). van der Gaag NA, de Castro SM, Rauws EA, Bruno MJ, van Eijck CH, Kuipers EJ, Gerritsen JJ, Rutten JP, Greve JW, Hesselink EJ, Klinkenbijl JH, Rinkes IH, Boerma D, Bonsing BA, van Laarhoven CJ, Kubben FJ, van der Harst E, Sosef MN, Bosscha K, de Hingh IH, Th de Wit L, van Delden OM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. BMC Surg. 2007 Mar 12;7:3. 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. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Sewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. Ann Surg. 2002 Jul;236(1):17-27.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 102

Inclusion Criteria

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 before inclusion;

Exclusion Criteria

1. Age > 85 years or severe co-morbidity (Karnofsky <50%) and other contra indications for major surgery;

2. Cholangitis/infection;

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence of stent-related complications after preoperative biliary drainage with a metal stent. These results will be compared to those of the patients from the previous DROP trial (NTR NUMBER: NTR234) who underwent preoperative drainage with a plastic stent as well as patients without stenting.

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>These results will be compared to those of the patients from the previous DROP trial (NTR NUMBER: NTR234) who underwent preoperative drainage with a plastic stent as well as patients without stenting.