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Pancreatitis, ENdoscopic transGastric versUs primary necrosectomy in patients with Infected Necrosis
ISRCTN ISRCTN07091918
DOI 10.1186/ISRCTN07091918
ClinicalTrials.gov identifier
EudraCT number
Public title Pancreatitis, ENdoscopic transGastric versUs primary necrosectomy in patients with Infected Necrosis
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
Serial number at source N/A
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.
Lay summary Not provided at time of registration
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
Countries of recruitment Netherlands
Disease/condition/study domain Acute necrotising pancreatitis
Participants - 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
Participants - 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
Anticipated start date 01/03/2007
Anticipated end date 01/03/2009
Status of trial Completed
Patient information material
Target number of participants 20
Interventions Endoscopic transgastric necrosectomy or necrosectomy by laparotomy, followed by continuous post-operative lavage
Primary outcome measure(s) 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 measure(s) 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
Sources of funding University Medical Centre Utrecht (UMCU) (Netherlands)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22416101
Contact name Dr  Robin  Timmer
  Address St Antonius Hospital
Department of Gastroenterology
P.O. Box 2500
  City/town Nieuwegein
  Zip/Postcode 3402 EM
  Country Netherlands
  Email r.timmer@antonius.net
Sponsor St Antonius Hospital Nieuwegein (Netherlands)
  Address Department of Gastroenterology
P.O. Box 2500
  City/town Nieuwegein
  Zip/Postcode 3402 EM
  Country Netherlands
  Sponsor website: http://www.antonius.net/rood/english.php
Date applied 11/12/2006
Last edited 21/03/2012
Date ISRCTN assigned 28/03/2007
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