Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial

S. A. Bouwense, M.G. Besselink, S. van Brunschot, O.J. Bakker, H.C. van Santvoort, N. J. Schepers, M.A. Boermeester, T.L. Bollen, K. Bosscha, M.A. Brink, M.J. Bruno, E.C. Consten, C.H.C. Dejong, P. van Duijvendijk, C.H. van Eijck, J.J. Gerritsen, H. van Goor, J. Heisterkamp, I.H. de Hingh, P.M. KruytI.Q. Molenaar, V.B. Nieuwenhuijs, C. Rosman, A.F. Schaapherder, J. J. Scheepers, M.B. Spanier, R. Timmer, B.L. Weusten, B.J. Witteman, B. van Ramshorst, H.G. Gooszen, D. Boerma

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Abstract

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. DISCUSSION: 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.Trial registrationCurrent Controlled Trials: ISRCTN72764151.
Original languageEnglish
Article number225
Pages (from-to)225
Number of pages10
JournalTrials
Volume13
Issue number1
DOIs
Publication statusPublished - 26 Nov 2012

Keywords

  • Acute pancreatitis
  • Gallstones
  • Trial
  • Common bile duct
  • Cholecystitis
  • Endoscopic retrograde cholangiopancreaticography
  • Surgery
  • Cholecystectomy
  • Timing
  • Mortality
  • ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
  • LAPAROSCOPIC CHOLECYSTECTOMY
  • GALLSTONE PANCREATITIS
  • CONSERVATIVE TREATMENT
  • GUIDELINES
  • SPHINCTEROTOMY
  • ACID

Cite this

Bouwense, S. A., Besselink, M. G., van Brunschot, S., Bakker, O. J., van Santvoort, H. C., Schepers, N. J., Boermeester, M. A., Bollen, T. L., Bosscha, K., Brink, M. A., Bruno, M. J., Consten, E. C., Dejong, C. H. C., van Duijvendijk, P., van Eijck, C. H., Gerritsen, J. J., van Goor, H., Heisterkamp, J., de Hingh, I. H., ... Boerma, D. (2012). Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial. Trials, 13(1), 225. [225]. https://doi.org/10.1186/1745-6215-13-225