Contact information
Type
Scientific
Primary contact
Prof H G Gooszen
ORCID ID
Contact details
Dutch Pancreatitis Study Group
Department of Surgery
Radboud University Nijmegen Medical Centre
HP 690
PO Box 9101
Nijmegen
6500HB
Netherlands
+31 (0)243 655764 / 66458
H.Gooszen@ok.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Pancreatitis of biliary origin: Optimal timiNg CHOlecystectomy (PONCHO) trial. A randomised controlled multicentre trial of the Dutch Pancreatitis Study Group.
Acronym
PONCHO
Study hypothesis
Current hypothesis as of 24/04/2012
We hypothesise that early timing of laparoscopic cholecystectomy (ELC) would reduce 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 and in accordance with the Medical Research Involving Human Subjects Act (WMO).
Previous 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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Mild biliary pancreatitis
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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)
Secondary outcome measures
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
Overall trial start date
01/01/2011
Overall trial end date
01/07/2013
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
266
Participant exclusion criteria
Curent exclusion criteria as of 24/04/2012
1. Patients <18 years
2. 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 <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
Recruitment start date
01/01/2011
Recruitment end date
01/07/2013
Locations
Countries of recruitment
Netherlands
Trial participating centre
Dutch Pancreatitis Study Group
Nijmegen
6500HB
Netherlands
Sponsor information
Organisation
Radboud University Nijmegen Medical Centre (Netherlands)
Sponsor details
Dutch Pancreatitis Study Group
Department of Surgery
HP 557
PO Box 9101
Mobile: +31 (0)617401029
Nijmegen
6500HB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Radboud University Nijmegen Medical Centre (Netherlands) - internal funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23181667
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26460661
Publication citations
-
Protocol
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, , Pancreatitis of biliary origin, optimal timing of cholecystectomy (PONCHO trial): study protocol for a randomized controlled trial., Trials, 2012, 13, 225, doi: 10.1186/1745-6215-13-225.