Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis: a prospective randomised trial
ISRCTN | ISRCTN04572410 |
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DOI | https://doi.org/10.1186/ISRCTN04572410 |
Secondary identifying numbers | N/A |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 17/09/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Djuna Cahen
Scientific
Scientific
Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Phone | +31 (0)20 3474723 |
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Djunacahen@hotmail.com |
Study information
Study design | Randomised, active controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | CEPAN |
Study objectives | To compare endoscopic and surgical drainage of the pancreatic duct. |
Ethics approval(s) | Ethics approval received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Chronic pancreatitis (CP) |
Intervention | 1. Surgical drainage: pancreaticojejunostomy 2. Endoscopic drainage: extracorporeal shock wave lithotripsy (ESWL) and/or pancreatic stenting |
Intervention type | Other |
Primary outcome measure | 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 study start date | 01/01/2000 |
Completion date | 01/10/2004 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 39 |
Key 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 |
Key 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 |
Date of first enrolment | 01/01/2000 |
Date of final enrolment | 01/10/2004 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Website | http://www.amc.uva.nl/ |
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https://ror.org/03t4gr691 |
Funders
Funder type
Industry
AstraZeneca (The Netherlands) - unrestricted grant
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | Results | 15/02/2007 | Yes | No |