Early Surgery versus optimal Current step-up prActice for chronic PancrEatitis.
- Conditions
- Chronic pancreatitis
- Registration Number
- NL-OMON27341
- Lead Sponsor
- Academic Medical Center AmsterdamDepartment of Surgery PO Box 22660, 1100 DD AmsterdamTel: +31205662666Fax: +31205669243
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 88
Inclusion Criteria
Registration criteria:
1. Age 18 years;
Exclusion Criteria
1. History of prolonged need of opioids for chronic pancreatitis for a period over 2 months in the last 2 years;
2. Previous pancreatic surgery;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary clinical outcome is the degree of pain as assessed by the Izbicki pain score at 2 weeks intervals during the follow-up period of 18 months.
- Secondary Outcome Measures
Name Time Method 1. Cost-effectiveness, total direct and indirect costs;<br /><br>2. Severe complications related to disease progression, or endoscopic and surgical interventions;<br /><br>3. Quality of life;<br /><br>4. Izbicki score at 18 months follow-up;<br /><br>5. Endocrine pancreatic insufficiency;<br /><br>6. Exocrine pancreatic insufficiency;<br /><br>7. Additional pain measurements;<br /><br>8. Number and duration of hospital admissions during study period;<br /><br>9. Number of performed interventions;<br /><br>10. Number of pancreatitis flair ups during study period.