TY - JOUR
T1 - Preoperative Biliary Drainage for Cancer of the Head of the Pancreas
AU - van der Gaag, Niels A.
AU - Rauws, Erik A. J.
AU - van Eijck, Casper H. J.
AU - Bruno, Marco J.
AU - van der Harst, Erwin
AU - Kubben, Frank J. G. M.
AU - Gerritsen, Josephus J. G. M.
AU - Greve, Jan Willem
AU - Gerhards, Michael F.
AU - de Hingh, Ignace H. J. T.
AU - Klinkenbijl, Jean H.
AU - Nio, Chung Y.
AU - de Castro, Steve M. M.
AU - Busch, Olivier R. C.
AU - van Gulik, Thomas M.
AU - Bossuyt, Patrick M.
AU - Gouma, Dirk J.
PY - 2010/1/14
Y1 - 2010/1/14
N2 - 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 mu mol 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
AB - 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 mu mol 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
U2 - 10.1056/NEJMoa0903230
DO - 10.1056/NEJMoa0903230
M3 - Article
C2 - 20071702
SN - 0028-4793
VL - 362
SP - 129
EP - 137
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 2
ER -