Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial).
BACKGROUND
Surgery in patients with obstructive jaundice caused by a periampullary (pancreas, papilla, distal bile duct) tumor is associated with a higher risk of postoperative complications than in non-jaundiced patients. Preoperative biliary drainage was introduced in an attempt to improve the general condition and thus reduce postoperative morbidity and mortality. Early studies showed a reduction in morbidity. However, more recently the focus has shifted towards the negative effects of drainage, such as an increase of infectious complications. Whether biliary drainage should always be performed in jaundiced patients remains controversial. The randomized controlled multicenter DROP-trial (DRainage vs. Operation) was conceived to compare the outcome of a 'preoperative biliary drainage strategy' (standard strategy) with that of an 'early-surgery' strategy, with respect to the incidence of severe complications (primary-outcome measure), hospital stay, number of invasive diagnostic tests, costs, and quality of life.


METHODS
Patients with obstructive jaundice due to a periampullary tumor, eligible for exploration after staging with CT scan, and scheduled to undergo a "curative" resection, will be randomized to either "early surgical treatment" (within one week) or "preoperative biliary drainage" (for 4 weeks) and subsequent surgical treatment (standard treatment). Primary outcome measure is the percentage of severe complications up to 90 days after surgery. The sample size calculation is based on the equivalence design for the primary outcome measure. If equivalence is found, the comparison of the secondary outcomes will be essential in selecting the preferred strategy. Based on a 40% complication rate for early surgical treatment and 48% for preoperative drainage, equivalence is taken to be demonstrated if the percentage of severe complications with early surgical treatment is not more than 10% higher compared to standard treatment: preoperative biliary drainage. Accounting for a 10% dropout, 105 patients are needed in each arm resulting in a study population of 210 (alpha = 0.95, beta = 0.8).


CONCLUSIONS
The DROP-trial is a randomized controlled multicenter trial that will provide evidence whether or not preoperative biliary drainage is to be performed in patients with obstructive jaundice due to a periampullary tumor.
van der Gaag
Niels A
NA
Department of Surgery, Academic Medical Center Amsterdam, The Netherlands. n.a.vandergaag@amc.uva.nl
de Castro
Steve M M
SM
Rauws
Erik A J
EA
Bruno
Marco J
MJ
van Eijck
Casper H J
CH
Kuipers
Ernst J
EJ
Gerritsen
Josephus J G M
JJ
Rutten
Jan-Paul
JP
Greve
Jan Willem
JW
Hesselink
Erik J
EJ
Klinkenbijl
Jean H G
JH
Rinkes
Inne H M  Borel
IH
Boerma
Djamila
D
Bonsing
Bert A
BA
van Laarhoven
Cees J
CJ
Kubben
Frank J G M
FJ
van der Harst
Erwin
E
Sosef
Meindert N
MN
Bosscha
Koop
K
de Hingh
Ignace H J T
IH
Th de Wit
Laurens
L
van Delden
Otto M
OM
Busch
Olivier R C
OR
van Gulik
Thomas M
TM
Bossuyt
Patrick M M
PM
Gouma
Dirk J
DJ
D014670:Ampulla of Vater; D001646:Bile; D002760:Cholangiopancreatography, Endoscopic Retrograde; D003138:Common Bile Duct Neoplasms / Q000150:complications / Q000601:surgery*; D004322:Drainage; D006801:Humans; D041781:Jaundice, Obstructive / Q000209:etiology / Q000628:therapy*; D010190:Pancreatic Neoplasms / Q000150:complications / Q000601:surgery*; D016577:Pancreaticoduodenectomy; D015607:Stents