A phase I/II study of transjugular-transhepatic peritoneo-venous shunting for malignant ascites (JIVROSG-0201)
Phase 1
- Conditions
- Cancer-related refractory ascites
- Registration Number
- JPRN-C000000262
- Lead Sponsor
- Japan Interventional Radiology in Oncology Study Group (JIVROSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
Not provided
Exclusion Criteria
1) Controllable ascites by standard anti-cancer therapies. 2) Intracavitary administration of anti-cancer agent is scheduled. 3) Controllable ascites by vascular interventions. 4) No symptom due to ascites. 5) Ascites due to malignatnt mesothelioma, mucin-producting tumor, pseudomyxoma. 6) Bloody, chylous or cloudy ascites. 7) Tumor or dilated intestine along the planned route for catheterization. 8) Active infection. 9) Untreated esophageal varices with red-color sign. 10) Active bleeding from upper digestive tract. 11) Post hepatic lobectomy. 12) Cardiac pacemaker. 13) Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events
- Secondary Outcome Measures
Name Time Method Improvement of symptom, decrease of ascites and body weight, elimination of