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