Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis: a prospective randomised trial

ISRCTN ISRCTN04572410
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

Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone +31 (0)20 3474723
Email Djunacahen@hotmail.com

Study information

Study designRandomised, active controlled, parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymCEPAN
Study objectivesTo 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) studiedChronic pancreatitis (CP)
Intervention1. Surgical drainage: pancreaticojejunostomy
2. Endoscopic drainage: extracorporeal shock wave lithotripsy (ESWL) and/or pancreatic stenting
Intervention typeOther
Primary outcome measureMean Izbicki pain score during follow-up
Secondary outcome measuresClinical 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 date01/01/2000
Completion date01/10/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participants39
Key inclusion criteria1. 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 criteria1. 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 enrolment01/01/2000
Date of final enrolment01/10/2004

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Academic Medical Center
Amsterdam
1105 AZ
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website http://www.amc.uva.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Industry

AstraZeneca (The Netherlands) - unrestricted grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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