Prospective, randomised, single-blind study for validation of the effect of endoscopic stent implantation and drainage on patients with chronic pancreatitis and pancreas duct stenosis
Completed
- Conditions
- Chronic pancreatitis with pancreatic duct stenosisDigestive SystemPancreatitis
- Registration Number
- ISRCTN13044540
- Lead Sponsor
- niversity of Leipzig (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
1. Chronic pancreatitis with evidence of magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)
pancreatic duct stricture (>50%) in pancreatic head
2. Chronic recurrent pain
3. Age >18, <75, WIC
Exclusion Criteria
1. Radiation of upper abdominal or lower chest area
2. Uncured cancer or systemic chemotherapy within last 5 years
3. Failure of compliance
4. Foreseeable
pregnancy
5. Participation in other therapeutic trials within last 30 days
6. Patients continuous free of symptoms
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total pain score during first 3 month after ERCP, specialised Pancreas Pain Questionaire checked for reliability and validity
- Secondary Outcome Measures
Name Time Method 1. Use af analgesics<br>2. Frequency of pain episodes within one year<br>3. Treatment failure<br>4. Signs of endocrine/exocrine failure<br>5. Change of diameter of pancreatic duct during treatment