Contact information
Type
Scientific
Primary contact
Dr Djuna Cahen
ORCID ID
Contact details
Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 3474723
Djunacahen@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
CEPAN
Study hypothesis
To compare endoscopic and surgical drainage of the pancreatic duct.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic pancreatitis (CP)
Intervention
1. Surgical drainage: pancreaticojejunostomy
2. Endoscopic drainage: extracorporeal shock wave lithotripsy (ESWL) and/or pancreatic stenting
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Mean Izbicki pain score during follow-up
Secondary outcome measures
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
Overall trial start date
01/01/2000
Overall trial end date
01/10/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
39
Participant 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
Recruitment start date
01/01/2000
Recruitment end date
01/10/2004
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
AstraZeneca (The Netherlands) - unrestricted grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/17301298
Publication citations
-
Results
Cahen DL, Gouma DJ, Nio Y, Rauws EA, Boermeester MA, Busch OR, Stoker J, Laméris JS, Dijkgraaf MG, Huibregtse K, Bruno MJ, Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis., N. Engl. J. Med., 2007, 356, 7, 676-684, doi: 10.1056/NEJMoa060610.