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ISRCTN
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ISRCTN13975868
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ClinicalTrials.gov identifier
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Public title
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Minimally invasive step up approach versus maximal necrosectomy in patients with acute necrotising pancreatitis
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Scientific title
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Minimally invasive step up approach versus maximal necrosectomy in patients with acute necrotising pancreatitis: a randomised controlled trial by the Dutch Acute Pancreatitis Study Group
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Acronym
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PANTER
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Serial number at source
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04-289
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Study hypothesis
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Minimally invasive step up approach, as compared to laparotomy, is capable of reducing major morbidity in patients with infected necrotising pancreatitis.
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Lay summary
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Ethics approval
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This study is conducted in accordance with the principles of the Declaration of Helsinki and 'good clinical practice' guidelines. The independent medical ethics committees of all 20 participating hospitals have approved the study protocol. Prior to randomisation, written informed consent will be obtained from all patients (alternatively consent by proxy will be obtained for patients who are unable to give consent, e.g., intubated patients).
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Study design
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Randomised controlled 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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Infected necrotising pancreatitis
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Participants - inclusion criteria
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Patients of all Dutch University Medical Centers and 12 teaching hospitals who are diagnosed with (suspected) infected necrotising pancreatitis:
1. Aged equal to or above 18 years
2. Pancreatic necrosis or peripancreatic necrosis detected on CECT
3. Patients in whom a decision for surgical intervention has been made because of (suspected) infected (peri-)pancreatic necrosis
4. Possibility of placing a drain (either percutaneous or endoscopic) in the collection(s)
5. Written informed consent
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Participants - exclusion criteria
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1. Previous percutaneous drainage, endoscopic drainage or surgical necrosectomy for necrotising pancreatitis (endoscopic retrograde cholangio-pancreatography [ERCP] for biliary pancreatitis is allowed)
2. Acute attack in a patient with chronic pancreatitis
3. Participation in another intervention trial that would interfere with the intervention and outcome of this study
4. Acute primary intervention because of ‘acute abdomen’, bleeding or perforation of a visceral organ
5. Post-operative (i.e. abdominal surgery) necrotising pancreatitis
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Anticipated start date
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01/05/2005
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Anticipated end date
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31/05/2008
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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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94
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Interventions
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Minimally invasive step up approach: percutaneous catheter drainage, when necessary followed by minimally invasive surgical necrosectomy versus laparotomy and continuous postoperative lavage.
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Primary outcome measure(s)
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Complications and mortality, expressed as the percentage of patients who died or had one or more of the complications listed in the protocol. Each complication will be assessed separately.
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Secondary outcome measure(s)
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1. Hospital and intensive care stay
2. Total indirect and direct costs
3. Hospital stay after first intervention
4. Duration of intubation after first intervention
5. Quality of life
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Sources of funding
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The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 945-06-910)
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Trial website
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http://www.pancreatitis.nl/
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Publications
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1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16606471
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20410514
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Contact name
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Prof
H G
Gooszen
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Address
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Heidelberglaan 100
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City/town
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Utrecht
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Zip/Postcode
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3584CX
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Country
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Netherlands
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Tel
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+31 (0)30 250 8074
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Fax
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+31 (0)30 254 1944
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Email
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h.gooszen@umcutrecht.nl
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Sponsor
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University Medical Centre Utrecht (UMCU) (Netherlands)
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Address
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c/o Prof H.G. Gooszen
P.O. Box 85500
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City/town
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Utrecht
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Zip/Postcode
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3508GA
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Country
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Netherlands
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Tel
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+31 (0)30 250 8074
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Fax
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+31 (0)30 254 1944
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Email
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h.gooszen@umcutrecht.nl
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Sponsor website:
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http://www.umcutrecht.nl/zorg/
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Date applied
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22/04/2005
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Last edited
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27/04/2010
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Date ISRCTN assigned
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26/04/2005
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