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11 February 2012
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| [ Print-friendly version ] |
| Pancreatitis of biliary origin: Optimal timiNg CHOlecystectomy (PONCHO) trial |
| ISRCTN | ISRCTN72764151 |
| ClinicalTrials.gov identifier | |
| Public title | Pancreatitis of biliary origin: Optimal timiNg CHOlecystectomy (PONCHO) trial |
| Scientific title | Pancreatitis of biliary origin: Optimal timiNg CHOlecystectomy (PONCHO) trial. A randomised controlled multicentre trial of the Dutch Pancreatitis Study Group. |
| Acronym | PONCHO |
| Serial number at source | N/A |
| Study hypothesis |
We hypothesise that early timing of laparoscopic cholecystectomy (ELC) would prevent recurrent biliary pancreatitis or other complications of gall-stone disease in patients with mild biliary pancreatitis.
Study conducted in accordance with the principles of the Declaration of Helsinki. |
| Lay summary | |
| Ethics approval |
Approved by the Arnhem-Nijmegen Regional Committee on Research Involving Human Subjects (Commissie Mensgebonden Onderzoek [CMO] regio Arnhem-Nijmegen).
The study protocol will also be approved by all participating hospitals. |
| Study design | Multicentre randomised controlled parallel group superiority trial |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Mild biliary pancreatitis |
| Participants - 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) |
| Participants - exclusion criteria |
1. Patients <18 years
2. 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 |
| Anticipated start date | 01/01/2011 |
| Anticipated end date | 01/07/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use contact details below to request a patient information sheet |
| Target number of participants | 266 |
| 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 randomised when the treating physician feels the patient can be discharged within 1-2 days and all signs of acute disease have resolved. |
| Primary outcome measure(s) | Composite endpoint: Unplanned re-admission for biliary events (recurrent biliary pancreatitis, acute cholecystitis, choledocholithiasis mandating ERCP, biliary colics) |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Radboud University Nijmegen Medical Centre (Netherlands) - internal funding |
| Trial website | http://www.pancreatitis.nl |
| Publications | |
| Contact name | Prof H G Gooszen |
| Address |
Dutch Pancreatitis Study Group
Department of Surgery Radboud University Nijmegen Medical Centre HP 690 PO Box 9101 |
| City/town | Nijmegen |
| Zip/Postcode | 6500HB |
| Country | Netherlands |
| Tel | +31 (0)243 655764 / 66458 |
| Fax | +31 (0)243 613834 |
| H.Gooszen@ok.umcn.nl | |
| Sponsor | Radboud University Nijmegen Medical Centre (Netherlands) |
| Address |
Dutch Pancreatitis Study Group
Department of Surgery HP 557 PO Box 9101 Mobile: +31 (0)617401029 |
| City/town | Nijmegen |
| Zip/Postcode | 6500HB |
| Country | Netherlands |
| Sponsor website: | http://www.pancreatitis.nl |
| Date applied | 26/05/2010 |
| Last edited | 29/06/2010 |
| Date ISRCTN assigned | 29/06/2010 |
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| © 2012 ISRCTN unless otherwise stated. | |
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