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Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis: a prospective randomised trial
ISRCTN ISRCTN04572410
DOI 10.1186/ISRCTN04572410
ClinicalTrials.gov identifier
EudraCT number
Public title Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis: a prospective randomised trial
Scientific title
Acronym CEPAN
Serial number at source N/A
Study hypothesis To compare endoscopic and surgical drainage of the pancreatic duct.
Lay summary
Ethics approval Ethics approval received from the local medical ethics committee
Study design Randomised, active controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Chronic pancreatitis (CP)
Participants - inclusion criteria 1. A diagnosis of CP, based on clinical symptoms in combination with morphological changes established by imaging studies (calcifications or ductal changes) and/or pancreatic functional insufficiency
2. A dominant obstruction of the pancreatic duct, demonstrated by presence of a stenosis and/or intraductal stones on magnetic resonance cholangiopancreatography (MRCP) and abdominal computed tomography (CT) scan, located left from the spine, with pre-stenotic ductal dilatation of at least 5 mm
3. Severe recurrent pancreatic pain with insufficient relieve by non-narcotic analgesics or requiring opiates
Participants - exclusion criteria 1. Age below 18 or over 80 years
2. Pancreatic head enlargement greater than 4 cm
3. Contra-indication for surgery; American Society of Anaesthesiologists (ASA) class 4, severe portal hypertension
4. Contra-indications for endoscopy: gastrectomy with Billroth II reconstruction, other pancreatitis related complications (bile duct stricture, pseudocyst) requiring surgery
5. Previous pancreatic surgery
6. Suspected pancreatic malignancy
7. Limited life expectancy (less than 2 years)
8. Pregnancy
Anticipated start date 01/01/2000
Anticipated end date 01/10/2004
Status of trial Completed
Patient information material
Target number of participants 39
Interventions 1. Surgical drainage: pancreaticojejunostomy
2. Endoscopic drainage: extracorporeal shock wave lithotripsy (ESWL) and/or pancreatic stenting
Primary outcome measure(s) Mean Izbicki pain score during follow-up
Secondary outcome measure(s) Clinical success:
1. Pain relief at end of FU
2. Complete (Izbicki pain score less than or equal to 10)
3. Partial (greater than 50% decrease, total score greater than 10)
4. Morbidity and mortality rate
5. Intervention rate
6. Hospital stay
7. Development of endo- and/or exocrine pancreatic insufficiency
Sources of funding AstraZeneca (The Netherlands) - unrestricted grant
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/17301298
Contact name Dr  Djuna  Cahen
  Address Academic Medical Center
Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Tel +31 (0)20 3474723
  Email Djunacahen@hotmail.com
Sponsor Academic Medical Centre (AMC) (Netherlands)
  Address Meibergdreef 9
  City/town Amsterdam
  Zip/Postcode 1105 AZ
  Country Netherlands
  Sponsor website: http://www.amc.uva.nl/
Date applied 20/12/2005
Last edited 17/09/2008
Date ISRCTN assigned 20/12/2005
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