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

ISRCTN	ISRCTN72764151
DOI	https://doi.org/10.1186/ISRCTN72764151
Secondary identifying numbers	N/A

Submission date: 26/05/2010
Registration date: 29/06/2010
Last edited: 16/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof H G Gooszen
Scientific

Dutch Pancreatitis Study Group
Department of Surgery
Radboud University Nijmegen Medical Centre
HP 690
PO Box 9101
Nijmegen
6500HB
Netherlands

Phone	+31 (0)243 655764 / 66458
Email	H.Gooszen@ok.umcn.nl

Study information

Study design	Multicentre randomised controlled parallel group superiority trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Pancreatitis of biliary origin: Optimal timiNg CHOlecystectomy (PONCHO) trial. A randomised controlled multicentre trial of the Dutch Pancreatitis Study Group.
Study acronym	PONCHO
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2011
Completion date	01/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	266
Key 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)
Key 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
Date of first enrolment	01/01/2011
Date of final enrolment	01/07/2013

Locations

Countries of recruitment

Netherlands

Study participating centre

Dutch Pancreatitis Study Group

Nijmegen
6500HB
Netherlands

Sponsor information

Radboud University Nijmegen Medical Centre (Netherlands)
Hospital/treatment centre

Dutch Pancreatitis Study Group
Department of Surgery
HP 557
PO Box 9101
Mobile: +31 (0)617401029
Nijmegen
6500HB
Netherlands

Website	http://www.pancreatitis.nl
"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Hospital/treatment centre

Radboud University Nijmegen Medical Centre (Netherlands) - internal funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	26/11/2012		Yes	No
Results article	results	26/09/2015		Yes	No

Editorial Notes

16/10/2015: Publication reference added.