title: Preoperative biliary drainage for cancer of the head of the pancreas.
abstract: BACKGROUND
  The benefits of preoperative biliary drainage, which was introduced to improve the postoperative outcome in patients with obstructive jaundice caused by a tumor of the pancreatic head, are unclear.
  
  
  METHODS
  In this multicenter, randomized trial, we compared preoperative biliary drainage with surgery alone for patients with cancer of the pancreatic head. Patients with obstructive jaundice and a bilirubin level of 40 to 250 micromol per liter (2.3 to 14.6 mg per deciliter) were randomly assigned to undergo either preoperative biliary drainage for 4 to 6 weeks, followed by surgery, or surgery alone within 1 week after diagnosis. Preoperative biliary drainage was attempted primarily with the placement of an endoprosthesis by means of endoscopic retrograde cholangiopancreatography. The primary outcome was the rate of serious complications within 120 days after randomization.
  
  
  RESULTS
  We enrolled 202 patients; 96 were assigned to undergo early surgery and 106 to undergo preoperative biliary drainage; 6 patients were excluded from the analysis. The rates of serious complications were 39% (37 patients) in the early-surgery group and 74% (75 patients) in the biliary-drainage group (relative risk in the early-surgery group, 0.54; 95% confidence interval [CI], 0.41 to 0.71; P<0.001). Preoperative biliary drainage was successful in 96 patients (94%) after one or more attempts, with complications in 47 patients (46%). Surgery-related complications occurred in 35 patients (37%) in the early-surgery group and in 48 patients (47%) in the biliary-drainage group (relative risk, 0.79; 95% CI, 0.57 to 1.11; P=0.14). Mortality and the length of hospital stay did not differ significantly between the two groups.
  
  
  CONCLUSIONS
  Routine preoperative biliary drainage in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. (Current Controlled Trials number, ISRCTN31939699.)
authors.affiliation: Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Niels A
authors.initials: NA
authors.lastname: van der Gaag
authors.forename: Erik A J
authors.initials: EA
authors.lastname: Rauws
authors.forename: Casper H J
authors.initials: CH
authors.lastname: van Eijck
authors.forename: Marco J
authors.initials: MJ
authors.lastname: Bruno
authors.forename: Erwin
authors.initials: E
authors.lastname: van der Harst
authors.forename: Frank J G M
authors.initials: FJ
authors.lastname: Kubben
authors.forename: Josephus J G M
authors.initials: JJ
authors.lastname: Gerritsen
authors.forename: Jan Willem
authors.initials: JW
authors.lastname: Greve
authors.forename: Michael F
authors.initials: MF
authors.lastname: Gerhards
authors.forename: Ignace H J T
authors.initials: IH
authors.lastname: de Hingh
authors.forename: Jean H
authors.initials: JH
authors.lastname: Klinkenbijl
authors.forename: Chung Y
authors.initials: CY
authors.lastname: Nio
authors.forename: Steve M M
authors.initials: SM
authors.lastname: de Castro
authors.forename: Olivier R C
authors.initials: OR
authors.lastname: Busch
authors.forename: Thomas M
authors.initials: TM
authors.lastname: van Gulik
authors.forename: Patrick M M
authors.initials: PM
authors.lastname: Bossuyt
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: Gouma
mesh_terms: D000368:Aged; D002760:Cholangiopancreatography, Endoscopic Retrograde / Q000009:adverse effects; D004322:Drainage / Q000009:adverse effects; D005260:Female; D006801:Humans; D041781:Jaundice, Obstructive / Q000209:etiology / Q000601:surgery; D007902:Length of Stay; D008197:Lymph Node Excision; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000150:complications / Q000601:surgery*; D016577:Pancreaticoduodenectomy / Q000009:adverse effects; D011183:Postoperative Complications / Q000453:epidemiology; D011300:Preoperative Care; D015607:Stents; D016896:Treatment Outcome