Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis: a prospective randomised trial
| ISRCTN | ISRCTN04572410 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04572410 |
| Protocol serial number | N/A |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | AstraZeneca (The Netherlands) - unrestricted grant |
- 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 |
|---|---|
| Djunacahen@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Mean Izbicki pain score during follow-up |
| Key secondary outcome measure(s) |
Clinical success: |
| Completion date | 01/10/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 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
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 15/02/2007 | Yes | No |
