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BMC Surgery
Published in: BMC Surgery 1/2006

Open Access 01-12-2006 | 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]

Authors: Marc GH Besselink, Hjalmar C van Santvoort, Vincent B Nieuwenhuijs, Marja A Boermeester, Thomas L Bollen, Erik Buskens, Cornelis HC Dejong, Casper HJ van Eijck, Harry van Goor, Sijbrand S Hofker, Johan S Lameris, Maarten S van Leeuwen, Rutger J Ploeg, Bert van Ramshorst, Alexander FM Schaapherder, Miguel A Cuesta, Esther CJ Consten, Dirk J Gouma, Erwin van der Harst, Eric J Hesselink, Lex PJ Houdijk, Tom M Karsten, Cees JHM van Laarhoven, Jean-Pierre EN Pierie, Camiel Rosman, Ernst Jan Spillenaar Bilgen, Robin Timmer, Ingeborg van der Tweel, Ralph J de Wit, Ben JM Witteman, Hein G Gooszen, members of the Dutch Acute Pancreatitis Study Group

Published in: BMC Surgery | Issue 1/2006

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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.
Appendix
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Metadata
Title
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]
Authors
Marc GH Besselink
Hjalmar C van Santvoort
Vincent B Nieuwenhuijs
Marja A Boermeester
Thomas L Bollen
Erik Buskens
Cornelis HC Dejong
Casper HJ van Eijck
Harry van Goor
Sijbrand S Hofker
Johan S Lameris
Maarten S van Leeuwen
Rutger J Ploeg
Bert van Ramshorst
Alexander FM Schaapherder
Miguel A Cuesta
Esther CJ Consten
Dirk J Gouma
Erwin van der Harst
Eric J Hesselink
Lex PJ Houdijk
Tom M Karsten
Cees JHM van Laarhoven
Jean-Pierre EN Pierie
Camiel Rosman
Ernst Jan Spillenaar Bilgen
Robin Timmer
Ingeborg van der Tweel
Ralph J de Wit
Ben JM Witteman
Hein G Gooszen
members of the Dutch Acute Pancreatitis Study Group
Publication date
01-12-2006
Publisher
BioMed Central
Published in
BMC Surgery / Issue 1/2006
Electronic ISSN: 1471-2482
DOI
https://doi.org/10.1186/1471-2482-6-6

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