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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22416101
Publication citations
-
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.