Preoperative biliary drainage for cancer of the head of the pancreas.
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.)
van der Gaag
Niels A
NA
Department of Surgery, Academic Medical Center, Amsterdam, The Netherlands.
Rauws
Erik A J
EA
van Eijck
Casper H J
CH
Bruno
Marco J
MJ
van der Harst
Erwin
E
Kubben
Frank J G M
FJ
Gerritsen
Josephus J G M
JJ
Greve
Jan Willem
JW
Gerhards
Michael F
MF
de Hingh
Ignace H J T
IH
Klinkenbijl
Jean H
JH
Nio
Chung Y
CY
de Castro
Steve M M
SM
Busch
Olivier R C
OR
van Gulik
Thomas M
TM
Bossuyt
Patrick M M
PM
Gouma
Dirk J
DJ
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