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ISRCTN
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ISRCTN04572410
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ClinicalTrials.gov identifier
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Public title
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Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis: a prospective randomised trial
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Scientific title
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Acronym
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CEPAN
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Serial number at source
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N/A
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Study hypothesis
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To compare endoscopic and surgical drainage of the pancreatic duct.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised, active controlled, parallel group 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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Chronic pancreatitis (CP)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2000
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Anticipated end date
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01/10/2004
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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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39
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Interventions
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1. Surgical drainage: pancreaticojejunostomy
2. Endoscopic drainage: extracorporeal shock wave lithotripsy (ESWL) and/or pancreatic stenting
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Primary outcome measure(s)
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Mean Izbicki pain score during follow-up
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Secondary outcome measure(s)
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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
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Sources of funding
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AstraZeneca (The Netherlands) - unrestricted grant
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/17301298
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Contact name
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Dr
Djuna
Cahen
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Address
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Academic Medical Center
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Tel
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+31 (0)20 3474723
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Email
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Djunacahen@hotmail.com
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Sponsor
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Academic Medical Centre (AMC) (Netherlands)
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Address
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Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Sponsor website:
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http://www.amc.uva.nl/
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Date applied
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20/12/2005
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Last edited
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17/09/2008
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Date ISRCTN assigned
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20/12/2005
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