Condition category
Digestive System
Date applied
11/12/2006
Date assigned
28/03/2007
Last edited
21/03/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robin Timmer

ORCID ID

Contact details

St Antonius Hospital
Department of Gastroenterology
P.O. Box 2500
Nieuwegein
3402 EM
Netherlands
r.timmer@antonius.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Pancreatitis, ENdoscopic transGastric versUs primary necrosectomy in patients with Infected Necrosis: a randomised controlled multicentre observer-blinded trial (Dutch Acute Pancreatitis Study Group)

Acronym

PENGUIN

Study hypothesis

Endoscopic transgastric necrosectomy will lead to a reduction of the pre- and post-operative pro-inflammatory response, as compared to necrosectomy by laparotomy, in patients with infected (peri-)pancreatic necrosis.

Ethics approval

Regional Medical Ethics Board for the Meander Medical Centre Amersfoort-Baarn-Soest (De Verenigde Commissies Mensgebonden Onderzoek [VCMO]) approved on the 17th April 2007 (ref: LTME/VL-07.08)

Study design

Randomised controlled multicentre observer-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Acute necrotising pancreatitis

Intervention

Endoscopic transgastric necrosectomy or necrosectomy by laparotomy, followed by continuous post-operative lavage

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Pro-inflammatory response as measured by the maximum increase in level of serum cytokine Interleukin six (IL-6) in the period between start of the first necrosectomy and five hours thereafter

Secondary outcome measures

1. Complications (bleeding, perforation, pancreatic fistula, pancreatic pseudocyst requiring intervention, pancreatic abscess requiring intervention, biliary strictures, incisional hernia requiring re-intervention and pancreatic insufficiency)
2. Mortality
3. Total number of interventions
4. Total hospital stay
5. Total intensive care stay

Overall trial start date

01/03/2007

Overall trial end date

01/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age equal to or above 18 years
2. Pancreatic necrosis or peripancreatic necrosis detected on contrast-enhanced computed tomography (CECT)
3. Patients in whom a decision for surgical intervention has been made because of (suspected) infected (peri-)pancreatic necrosis
4. Safe access route for endoscopic transgastric necrosectomy
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

1. Participation in another intervention trial that would interfere with the intervention and outcome of this study
2. Previous surgical necrosectomy for (suspected) infected pancreatic necrosis, including procedures performed in referring hospitals. Previous percutaneous or transgastric drainage is allowed
3. Previous exploratory laparotomy for acute abdomen and diagnosis of pancreatitis during laparotomy
4. Acute flare-up of chronic pancreatitis
5. Bleeding, abdominal compartment syndrome or perforation of a visceral organ as indication for intervention
6. Post-abdominal surgery necrotising pancreatitis

Recruitment start date

01/03/2007

Recruitment end date

01/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

St Antonius Hospital
Nieuwegein
3402 EM
Netherlands

Sponsor information

Organisation

St Antonius Hospital Nieuwegein (Netherlands)

Sponsor details

Department of Gastroenterology
P.O. Box 2500
Nieuwegein
3402 EM
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.antonius.net/rood/english.php

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Utrecht (UMCU) (Netherlands)

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

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22416101

Publication citations

  1. Results

    Bakker OJ, van Santvoort HC, van Brunschot S, Geskus RB, Besselink MG, Bollen TL, van Eijck CH, Fockens P, Hazebroek EJ, Nijmeijer RM, Poley JW, van Ramshorst B, Vleggaar FP, Boermeester MA, Gooszen HG, Weusten BL, Timmer R, , Endoscopic transgastric vs surgical necrosectomy for infected necrotizing pancreatitis: a randomized trial., JAMA, 2012, 307, 10, 1053-1061, doi: 10.1001/jama.2012.276.

Additional files

Editorial Notes