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

Completed

Conditions: Chronic pancreatitis (CP)
Digestive System

Registration Number: ISRCTN04572410

Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 39

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Izbicki pain score during follow-up

Secondary Outcome Measures

Name	Time	Method
Clinical success: <br>1. Pain relief at end of FU<br>2. Complete (Izbicki pain score less than or equal to 10)<br>3. Partial (greater than 50% decrease, total score greater than 10)<br>4. Morbidity and mortality rate<br>5. Intervention rate<br>6. Hospital stay <br>7. Development of endo- and/or exocrine pancreatic insufficiency