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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Djuna Cahen
Scientific

Academic Medical Center
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

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

Study design	Randomised, active controlled, parallel group trial
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

Participant type(s)	Patient
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

Academic Medical Center

Amsterdam
1105 AZ
Netherlands

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

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

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

Industry

AstraZeneca (The Netherlands) - unrestricted grant

No information available

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	15/02/2007		Yes	No