Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial
Stefan A Bouwense1, Marc G Besselink234, Sandra van Brunschot1, Olaf J Bakker2, Hjalmar C van Santvoort2, Nicolien J Schepers1, Marja A Boermeester4, Thomas L Bollen5, Koop Bosscha6, Menno A Brink7, Marco J Bruno8, Esther C Consten9, Cornelis H De Jong10, Peter van Duijvendijk 11, Casper H van Eijck12, Jos J Gerritsen13, Harry van Goor14, Joos Heisterkamp15, Ignace H de Hingh16, Philip M Kruyt17, I Quintus Molenaar2, Vincent B Nieuwenhuijs18, Camiel Rosman19, Alexander F Schaapherder20, Joris J Scheepers21, Marcel BW Spanier22, Robin Timmer23, Bas L Weusten23, Ben J Witteman24, Bert van Ramshorst3, Hein G Gooszen1, Djamila Boerma3* and for the Dutch Pancreatitis Study Group
1. Department of OR/Evidence Based Surgery, Radboud University Nijmegen Medical Centre, HP 690, PO 9101, Nijmegen, HB 6500, the Netherlands
2. Department of Surgery, University Medical Center Utrecht, HP G04.228, PO 85500, Utrecht, GA 3508, the Netherlands
3. Department of Surgery, St Antonius Hospital, PO 2500, Nieuwegein EM 3430, the Netherlands
4. Department of Surgery, Academic Medical Center, PO 22660, Amsterdam, DD 1100, the Netherlands
5. Department of Radiology, St Antonius Hospital, PO 2500, Nieuwegein, EM 3430, the Netherlands
6. Department of Surgery, Jeroen Bosch Hospital, PO 90153, Den Bosch, ME 5200, the Netherlands
7. Department of Gastroenterology, Meander Medical Center, PO 1502, Amersfoort, BM 3800, the Netherlands
8. Department of Gastroenterology, Erasmus Medical Center, PO 2040, Rotterdam, CA 3000, the Netherlands
9. Department of Surgery, Meander Medical Center, PO 1502, Amersfoort, BM 3800, the Netherlands
10. Department of Surgery, Maastricht University Medical Center and NUTRIM School for Nutrition, Toxicology and Metabolism, PO 5800, Maastricht, AZ 6202, the Netherlands
11. Department of Surgery, Gelre Hospital, PO 9014, Apeldoorn, DS 7300, the Netherlands
12. Department of Surgery, Erasmus Medical Center, PO 2040, Rotterdam, CA 3000, the Netherlands
13. Department of Surgery, Medisch Spectrum Twente, PO 50000, Enschede, KA 7500, the Netherlands
14. Department of Surgery, Radboud University Nijmegen Medical Centre, HP 690, PO 9101, Nijmegen, HB 6500, the Netherlands
15. Department of Surgery, St. Elisabeth Hospital, PO 90151, Tilburg, LC 5000, the Netherlands
16. Department of Surgery, Catharina Hospital, PO 1350, Eindhoven, EJ 5623, the Netherlands
17. Department of Surgery, Hospital Gelderse Vallei Ede, PO 9025, Ede, HN 6710, the Netherlands
18. Department of Surgery, University Medical Center Groningen, PO 30001, Groningen, RB 9700, the Netherlands
19. Department of Surgery, Canisius-Wilhelmina Hospital, PO 9015, Nijmegen, GS 6500, the Netherlands
20. Department of Surgery, Leiden University Medical Center, PO 9600, Leiden, RC 2300, the Netherlands
21. Department of Surgery, Reinier de Graaf Gasthuis, PO 5011, Delft, AD 2625, the Netherlands
22. Department of Gastroenterology, Rijnstate Hospital, PO 9555, Arnhem, TA 6800, the Netherlands
23. Department of Gastroenterology, St Antonius Hospital, PO 2500, Nieuwegein, EM 3430, the Netherlands
24. Department of Gastroenterology, Hospital Gelderse Vallei Ede, PO 9025, Ede, HN 6710, the Netherlands
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/DESIGN:
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 REGISTRATION:
Current Controlled Trials:ISRCTN72764151
