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Open Access Study protocol

Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial)

Niels A van der Gaag1*, Steve MM de Castro1, Erik AJ Rauws2, Marco J Bruno2, Casper HJ van Eijck3, Ernst J Kuipers4, Josephus JGM Gerritsen5, Jan-Paul Rutten6, Jan Willem Greve6, Erik J Hesselink7, Jean HG Klinkenbijl8, Inne HM Borel Rinkes9, Djamila Boerma10, Bert A Bonsing11, Cees J van Laarhoven12, Frank JGM Kubben13, Erwin van der Harst14, Meindert N Sosef15, Koop Bosscha16, Ignace HJT de Hingh17, Laurens Th de Wit18, Otto M van Delden19, Olivier RC Busch1, Thomas M van Gulik1, Patrick MM Bossuyt20 and Dirk J Gouma1

Author Affiliations

1 Department of Surgery, Academic Medical Center Amsterdam, the Netherlands

2 Department of Gastroenterology, Amsterdam, the Netherlands

3 Department of Surgery, Erasmus Medical Center, Rotterdam, the Netherlands

4 Department of Gastroenterology, Erasmus Medical Center, Rotterdam, the Netherlands

5 Department of Surgery, Medical Spectrum Twente, Enschede, the Netherlands

6 Department of Surgery, University Hospital Maastricht, Maastricht, the Netherlands

7 Department of Surgery, Gelre Hospital, Apeldoorn, the Netherlands

8 Department of Surgery, Rijnstate Hospital, Arnhem, the Netherlands

9 Department of Surgery, University Medical Center Utrecht, the Netherlands

10 Department of Surgery, St Antonius Hospital, Nieuwegein, the Netherlands

11 Department of Surgery, Leiden University Medical Center, the Netherlands

12 Department of Surgery, St Elisabeth Hospital, Tilburg, the Netherlands

13 Department of Gastroenterology, Medical Center Rijnmond Zuid, Rotterdam, the Netherlands

14 Department of Surgery, Medical Center Rijnmond Zuid, Rotterdam, the Netherlands

15 Department of Surgery, Atrium Medical Center, Heerlen, the Netherlands

16 Department of Surgery, Jeroen Bosch Hospital, 's Hertogenbosch, the Netherlands

17 Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands

18 Department of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands

19 Department of Radiology, Academic Medical Center Amsterdam, The Netherlands

20 Department of clinical epidemiology and biostatistics, Academic Medical Center Amsterdam, the Netherlands

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BMC Surgery 2007, 7:3  doi:10.1186/1471-2482-7-3

Published: 12 March 2007

Abstract

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/design

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).

Discussion

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.