title: Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  After an initial attack of biliary pancreatitis, cholecystectomy minimizes the risk of recurrent biliary pancreatitis and other gallstone-related complications. Guidelines advocate performing cholecystectomy within 2 to 4 weeks after discharge for mild biliary pancreatitis. During this waiting period, the patient is at risk of recurrent biliary events. In current clinical practice, surgeons usually postpone cholecystectomy for 6 weeks due to a perceived risk of a more difficult dissection in the early days following pancreatitis and for logistical reasons. We hypothesize that early laparoscopic cholecystectomy minimizes the risk of recurrent biliary pancreatitis or other complications of gallstone disease in patients with mild biliary pancreatitis without increasing the difficulty of dissection and the surgical complication rate compared with interval laparoscopic cholecystectomy.
  
  
  METHODS
  PONCHO is a randomized controlled, parallel-group, assessor-blinded, superiority multicenter trial. Patients are randomly allocated to undergo early laparoscopic cholecystectomy, within 72 hours after randomization, or interval laparoscopic cholecystectomy, 25 to 30 days after randomization. During a 30-month period, 266 patients will be enrolled from 18 hospitals of the Dutch Pancreatitis Study Group. The primary endpoint is a composite endpoint of mortality and acute re-admissions for biliary events (that is, recurrent biliary pancreatitis, acute cholecystitis, symptomatic/obstructive choledocholithiasis requiring endoscopic retrograde cholangiopancreaticography including cholangitis (with/without endoscopic sphincterotomy), and uncomplicated biliary colics) occurring within 6 months following randomization. Secondary endpoints include the individual endpoints of the composite endpoint, surgical and other complications, technical difficulty of cholecystectomy and costs.
  
  
  CONCLUSIONS
  The PONCHO trial is designed to show that early laparoscopic cholecystectomy (within 72 hours) reduces the combined endpoint of mortality and re-admissions for biliary events as compared with interval laparoscopic cholecystectomy (between 25 and 30 days) after recovery of a first episode of mild biliary pancreatitis.
  
  
  BACKGROUND
  Current Controlled Trials: ISRCTN72764151.
authors.affiliation: Department of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, HP 690, PO 9101, Nijmegen HB 6500, the Netherlands.
authors.forename: Stefan A
authors.initials: SA
authors.lastname: Bouwense
authors.forename: Marc G
authors.initials: MG
authors.lastname: Besselink
authors.forename: Sandra
authors.initials: S
authors.lastname: van Brunschot
authors.forename: Olaf J
authors.initials: OJ
authors.lastname: Bakker
authors.forename: Hjalmar C
authors.initials: HC
authors.lastname: van Santvoort
authors.forename: Nicolien J
authors.initials: NJ
authors.lastname: Schepers
authors.forename: Marja A
authors.initials: MA
authors.lastname: Boermeester
authors.forename: Thomas L
authors.initials: TL
authors.lastname: Bollen
authors.forename: Koop
authors.initials: K
authors.lastname: Bosscha
authors.forename: Menno A
authors.initials: MA
authors.lastname: Brink
authors.forename: Marco J
authors.initials: MJ
authors.lastname: Bruno
authors.forename: Esther C
authors.initials: EC
authors.lastname: Consten
authors.forename: Cornelis H
authors.initials: CH
authors.lastname: Dejong
authors.forename: Peter
authors.initials: P
authors.lastname: van Duijvendijk
authors.forename: Casper H
authors.initials: CH
authors.lastname: van Eijck
authors.forename: Jos J
authors.initials: JJ
authors.lastname: Gerritsen
authors.forename: Harry
authors.initials: H
authors.lastname: van Goor
authors.forename: Joos
authors.initials: J
authors.lastname: Heisterkamp
authors.forename: Ignace H
authors.initials: IH
authors.lastname: de Hingh
authors.forename: Philip M
authors.initials: PM
authors.lastname: Kruyt
authors.forename: I Quintus
authors.initials: IQ
authors.lastname: Molenaar
authors.forename: Vincent B
authors.initials: VB
authors.lastname: Nieuwenhuijs
authors.forename: Camiel
authors.initials: C
authors.lastname: Rosman
authors.forename: Alexander F
authors.initials: AF
authors.lastname: Schaapherder
authors.forename: Joris J
authors.initials: JJ
authors.lastname: Scheepers
authors.forename: Marcel B W
authors.initials: MB
authors.lastname: Spanier
authors.forename: Robin
authors.initials: R
authors.lastname: Timmer
authors.forename: Bas L
authors.initials: BL
authors.lastname: Weusten
authors.forename: Ben J
authors.initials: BJ
authors.lastname: Witteman
authors.forename: Bert
authors.initials: B
authors.lastname: van Ramshorst
authors.forename: Hein G
authors.initials: HG
authors.lastname: Gooszen
authors.forename: Djamila
authors.initials: D
authors.lastname: Boerma
mesh_terms: D017081:Cholecystectomy, Laparoscopic / Q000009:adverse effects / Q000191:economics / Q000401:mortality; D042882:Gallstones / Q000150:complications / Q000191:economics / Q000401:mortality / Q000601:surgery*; D017048:Health Care Costs; D006801:Humans; D009426:Netherlands; D010195:Pancreatitis / Q000191:economics / Q000209:etiology / Q000401:mortality / Q000517:prevention & control*; D010359:Patient Readmission; D012107:Research Design; D055502:Secondary Prevention; D013997:Time Factors; D061665:Time-to-Treatment; D016896:Treatment Outcome