Pancreatitis of biliary origin: Optimal timiNg CHOlecystectomy (PONCHO) trial

Conditions

Mild biliary pancreatitis Digestive System Acute pancreatitis

da Costa DW, Bouwense SA, Schepers NJ, Besselink MG, van Santvoort HC, van Brunschot S, Bakker OJ, Bollen TL, Dejong CH, van Goor H, Boermeester MA, Bruno MJ, van Eijck CH, Timmer R, Weusten BL, Consten EC, Brink MA, Spanier BWM, Bilgen EJS, Nieuwenhuijs VB, Hofker HS, Rosman C, Voorburg AM, Bosscha K, van Duijvendijk P, Gerritsen JJ, Heisterkamp J, de Hingh IH, Witteman BJ, Kruyt PM, Scheepers JJ, Molenaar IQ, Schaapherder AF, Manusama ER, van der Waaij LA, van Unen J, Dijkgraaf MG, van Ramshorst B, Gooszen HG, Boerma D, Dutch Pancreatitis Study Group.

2015-09-01212 citations

10.1016/s0140-6736(15)00274-3

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

Bouwense SA, Besselink MG, van Brunschot S, Bakker OJ, van Santvoort HC, Schepers NJ, Boermeester MA, Bollen TL, Bosscha K, Brink MA, Bruno MJ, Consten EC, Dejong CH, van Duijvendijk P, van Eijck CH, Gerritsen JJ, van Goor H, Heisterkamp J, de Hingh IH, Kruyt PM, Molenaar IQ, Nieuwenhuijs VB, Rosman C, Schaapherder AF, Scheepers JJ, Spanier MB, Timmer R, Weusten BL, Witteman BJ, van Ramshorst B, Gooszen HG, Boerma D, Dutch Pancreatitis Study Group.

2012-11-2628 citations

10.1186/1745-6215-13-225

Interventions

1. Intervention group: Laparoscopic cholecystectomy within 72 hours after randomisation (ELC). 2. Control group: Laparoscopic cholecystectomy 25-30 days after randomization (ILC). Patients are ran

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current inclusion criteria as of 24/04/2012 1. Age 18 years or older 2. Mild (non-severe) biliary pancreatitis; no pancreatic necrosis and/or peripancreatic collections and no persistent (>48hr) organ failure 3. First episode of acute pancreatitis 4. Written and oral informed consent (obtained prior to randomisation) Previous inclusion criteria 1. Age 18 years or older 2. Mild (non-severe) biliary pancreatitis, without sterile pancreatic necrosis and/or peripancreatic collections. 3. Written and oral informed consent (obtained prior to randomisation)

Exclusion criteria

Exclusion criteria: Curent exclusion criteria as of 24/04/2012 1. Patients 75 years with ASA III 3. ASA IV and V patients 4. Patients with ongoing alcohol abuse or chronic pancreatitis 5. Pregnancy Previous exclusion criteria 1. Patients 75 years with ASA III 3. ASA IV and V patients 4. Patients with history of alcohol abuse or chronic pancreatitis 5. Mild pancreatitis with sterile pancreatic necrosis and/or peripancreatic collections 6. Severe pancreatitis: persistent (>48hrs) organ failure or necrotizing pancreatitis

Design outcomes

Primary

Measure	Time frame
Current primary outcome as of 24/04/2012 Composite endpoint: Unplanned re-admission for biliary events (recurrent biliary pancreatitis, acute cholecystitis, choledocholithiasis mandating ERCP, biliary colics) and mortality Previous primary outcome Composite endpoint: Unplanned re-admission for biliary events (recurrent biliary pancreatitis, acute cholecystitis, choledocholithiasis mandating ERCP, biliary colics)	—

Measure

Time frame

Current primary outcome as of 24/04/2012 Composite endpoint: Unplanned re-admission for biliary events (recurrent biliary pancreatitis, acute cholecystitis, choledocholithiasis mandating ERCP, biliary colics) and mortality Previous primary outcome Composite endpoint: Unplanned re-admission for biliary events (recurrent biliary pancreatitis, acute cholecystitis, choledocholithiasis mandating ERCP, biliary colics)

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Secondary

Measure	Time frame
1. Individual components of the primary endpoint 2. Number of biliary colics after randomisation 3. Length of hospital stay 4. Operation difficulty (VAS) 5. Duration 6. Complications and conversion rate of laparoscopic cholecystectomy 7. Costs per primary endpoint avoided 8. Quality adjusted life year (QALY) gained 9. Mortality 10. Patient satisfaction	—

Countries

Netherlands

Outcome results

None listed