Condition category
Digestive System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/

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

  1. 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.

Additional files

Editorial Notes