Endoscopic versus surgical drainage of the pancreatic duct in chronic pancreatitis; a prospective randomised trial.
Completed
- Conditions
- Chronic pancreatitis (CP).
- Registration Number
- NL-OMON27733
- Lead Sponsor
- /A
- Brief Summary
1. Ned Tijdschr Geneeskd. 2007 Nov 24;151(47):2624-30.; <br> <br><br> 2. N Engl J Med. 2007 Feb 15;356(7):676-84.<br>
- 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 MRCP and abdominal CT-scan, located left from the spine, with pre-stenotic ductal dilatation of at least 5 mm;
Exclusion Criteria
1. Age below 18 or over 80 years;
2. Pancreatic head enlargement > 4 cm;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Izbicki painscore during follow-up.
- Secondary Outcome Measures
Name Time Method 1. Clinical success: pain relief at end of FU;<br /><br>2. Complete (Izbicki pain score ¡Ü 10);<br /><br>3. Partial (>50% decrease, total score > 10);<br><br />4. Morbidity and mortality rate;<br><br />5. Intervention rate;<br><br />6. Hospital stay; <br><br />7. Development of endo- and/or exocrine pancreatic insufficiency.