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Minimally invasive step up approach versus maximal necrosectomy in patients with acute necrotising pancreatitis
ISRCTN ISRCTN13975868
DOI 10.1186/ISRCTN13975868
ClinicalTrials.gov identifier
EudraCT number
Public title Minimally invasive step up approach versus maximal necrosectomy in patients with acute necrotising pancreatitis
Scientific title 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
Acronym PANTER
Serial number at source 04-289
Study hypothesis Minimally invasive step up approach, as compared to laparotomy, is capable of reducing major morbidity in patients with infected necrotising pancreatitis.
Lay summary
Ethics approval 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).
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Infected necrotising pancreatitis
Participants - inclusion criteria 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
Participants - exclusion criteria 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 Ďacute abdomení, bleeding or perforation of a visceral organ
5. Post-operative (i.e. abdominal surgery) necrotising pancreatitis
Anticipated start date 01/05/2005
Anticipated end date 31/05/2008
Status of trial Completed
Patient information material
Target number of participants 94
Interventions Minimally invasive step up approach: percutaneous catheter drainage, when necessary followed by minimally invasive surgical necrosectomy versus laparotomy and continuous postoperative lavage.
Primary outcome measure(s) 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.
Secondary outcome measure(s) 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
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) (ref: 945-06-910)
Trial website http://www.pancreatitis.nl/
Publications 1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16606471
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20410514
Contact name Prof  H G  Gooszen
  Address Heidelberglaan 100
  City/town Utrecht
  Zip/Postcode 3584CX
  Country Netherlands
  Tel +31 (0)30 250 8074
  Fax +31 (0)30 254 1944
  Email h.gooszen@umcutrecht.nl
Sponsor University Medical Centre Utrecht (UMCU) (Netherlands)
  Address c/o Prof H.G. Gooszen
P.O. Box 85500
  City/town Utrecht
  Zip/Postcode 3508GA
  Country Netherlands
  Tel +31 (0)30 250 8074
  Fax +31 (0)30 254 1944
  Email h.gooszen@umcutrecht.nl
  Sponsor website: http://www.umcutrecht.nl/zorg/
Date applied 22/04/2005
Last edited 27/04/2010
Date ISRCTN assigned 26/04/2005
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