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Open Access Study protocol

Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868]

Marc GH Besselink1, Hjalmar C van Santvoort1, Vincent B Nieuwenhuijs1, Marja A Boermeester2, Thomas L Bollen3, Erik Buskens4, Cornelis HC Dejong5, Casper HJ van Eijck6, Harry van Goor7, Sijbrand S Hofker8, Johan S Lameris9, Maarten S van Leeuwen, Rutger J Ploeg8, Bert van Ramshorst10, Alexander FM Schaapherder11, Miguel A Cuesta12, Esther CJ Consten13, Dirk J Gouma2, Erwin van der Harst14, Eric J Hesselink15, Lex PJ Houdijk16, Tom M Karsten17, Cees JHM van Laarhoven18, Jean-Pierre EN Pierie19, Camiel Rosman20, Ernst Jan Spillenaar Bilgen21, Robin Timmer22, Ingeborg van der Tweel23, Ralph J de Wit24, Ben JM Witteman25, Hein G Gooszen1* and members of the Dutch Acute Pancreatitis Study Group

Author Affiliations

1 Department of Surgery, University Medical Center Utrecht, The Netherlands

2 Department of Surgery, Academic Medical Center Amsterdam, The Netherlands

3 Department of Radiology, St. Antonius Hospital Nieuwegein, The Netherlands

4 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, The Netherlands

5 Department of Surgery, University Hospital Maastricht and NUTRIM institute, The Netherlands

6 Department of Surgery, Erasmus Medical Center Rotterdam, The Netherlands

7 Department of Surgery, Radboud University Nijmegen Medical Centre, The Netherlands

8 Department of Surgery, University Medical Center Groningen, The Netherlands

9 Department of Radiology, Academic Medical Center Amsterdam, 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, VU Medical Center Amsterdam, The Netherlands

13 Department of Surgery, Meander Medical Center Amersfoort, The Netherlands

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

15 Department of Surgery, Gelre Hospitals Apeldoorn, The Netherlands

16 Department of Surgery, Medical Center Alkmaar, The Netherlands

17 Department of Surgery, Reinier de Graaf Group Delft, The Netherlands

18 Department of Surgery, St. Elisabeth Hospital Tilburg, The Netherlands

19 Department of Surgery, Medical Center Leeuwarden, The Netherlands

20 Department of Surgery, Canisius Wilhelmina Hospital Nijmegen, The Netherlands

21 Department of Surgery, Rijnstate Hospital Arnhem, The Netherlands

22 Department of Gastroenterology, St. Antonius Hospital Nieuwegein, The Netherlands

23 Utrecht University, Centre for Biostatistics, The Netherlands

24 Department of Surgery, Medical Spectrum Twente, Enschede, The Netherlands

25 Department of Gastroenterology and Hepatology, Gelderse Vallei Ede, The Netherlands

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BMC Surgery 2006, 6:6  doi:10.1186/1471-2482-6-6

Published: 11 April 2006

Abstract

Background

The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision.

Methods/design

88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated.

Discussion

The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.