Condition category
Digestive System
Date applied
26/05/2010
Date assigned
29/06/2010
Last edited
16/10/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.pancreatitis.nl

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 measures

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

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

http://www.pancreatitis.nl

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

Results - basic reporting

Publication summary

2012 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23181667
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26460661

Publication citations

  1. 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.

Additional files

Editorial Notes

16/10/2015: Publication reference added.