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].
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
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, University Medical Center Utrecht, The Netherlands. m.besselink@umcutrecht.nl
authors.forename: Marc G H
authors.initials: MG
authors.lastname: Besselink
authors.forename: Hjalmar C
authors.initials: HC
authors.lastname: van Santvoort
authors.forename: Vincent B
authors.initials: VB
authors.lastname: Nieuwenhuijs
authors.forename: Marja A
authors.initials: MA
authors.lastname: Boermeester
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Bollen
authors.forename: Erik
authors.initials: E
authors.lastname: Buskens
authors.forename: Cornelis H C
authors.initials: CH
authors.lastname: Dejong
authors.forename: Casper H J
authors.initials: CH
authors.lastname: van Eijck
authors.forename: Harry
authors.initials: H
authors.lastname: van Goor
authors.forename: Sijbrand S
authors.initials: SS
authors.lastname: Hofker
authors.forename: Johan S
authors.initials: JS
authors.lastname: Lameris
authors.forename: Maarten S
authors.initials: MS
authors.lastname: van Leeuwen
authors.forename: Rutger J
authors.initials: RJ
authors.lastname: Ploeg
authors.forename: Bert
authors.initials: B
authors.lastname: van Ramshorst
authors.forename: Alexander F M
authors.initials: AF
authors.lastname: Schaapherder
authors.forename: Miguel A
authors.initials: MA
authors.lastname: Cuesta
authors.forename: Esther C J
authors.initials: EC
authors.lastname: Consten
authors.forename: Dirk J
authors.initials: DJ
authors.lastname: Gouma
authors.forename: Erwin
authors.initials: E
authors.lastname: van der Harst
authors.forename: Eric J
authors.initials: EJ
authors.lastname: Hesselink
authors.forename: Lex P J
authors.initials: LP
authors.lastname: Houdijk
authors.forename: Tom M
authors.initials: TM
authors.lastname: Karsten
authors.forename: Cees J H M
authors.initials: CJ
authors.lastname: van Laarhoven
authors.forename: Jean-Pierre E N
authors.initials: JP
authors.lastname: Pierie
authors.forename: Camiel
authors.initials: C
authors.lastname: Rosman
authors.forename: Ernst Jan Spillenaar
authors.initials: EJ
authors.lastname: Bilgen
authors.forename: Robin
authors.initials: R
authors.lastname: Timmer
authors.forename: Ingeborg
authors.initials: I
authors.lastname: van der Tweel
authors.forename: Ralph J
authors.initials: RJ
authors.lastname: de Wit
authors.forename: Ben J M
authors.initials: BJ
authors.lastname: Witteman
authors.forename: Hein G
authors.initials: HG
authors.lastname: Gooszen
mesh_terms: D004322:Drainage; D006801:Humans; D007813:Laparotomy / Q000379:methods*; D019283:Pancreatitis, Acute Necrotizing / Q000601:surgery*; D011182:Postoperative Care / Q000379:methods; D007507:Therapeutic Irrigation / Q000379:methods; D020535:Video-Assisted Surgery / Q000379:methods*