Randomized controlled trial of peritoneovenous shunting in patients with refractory ascites (JIVROSG-0803)
Phase 3
- Conditions
- Malignant refractory ascites
- Registration Number
- JPRN-UMIN000003469
- Lead Sponsor
- Japan Interventional Radiology in Oncology Study Group (JIVROSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Not provided
Exclusion Criteria
1. Non-malignant ascites 2. Previous peritoneovenous shunt 3. More than four weeks after the occurrence of refractory ascites 4. Bloody, mucinous or infectious ascites 5. Malignant peritoneal methothelioma 6. Ascites caused by liver cirrhosis 7. Clinically significant cardiac failure, renal failure, or bleeding tendency 8. Difficulties in the evaluation of quality-of-life 9. Pregnancy 10. Contraindication decided by attending physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of the symptoms from ascites.
- Secondary Outcome Measures
Name Time Method Improvement of health-related QOL/ toxicity profile/ survival time.