Feasibility of a fast-track randomised controlled trial of cell-free and concentrated ascites reinfusion therapy for patients with malignant ascites
- Conditions
- malignant ascites
- Registration Number
- JPRN-UMIN000031029
- Lead Sponsor
- Seirei Hospice, Seirei Mikatahara General Hospital
- Brief Summary
This study was an open-label, fast-track, randomized controlled, feasibility trial. Patients were randomly assigned 1:1 to a CART arm or control (simple paracentesis) arm. The feasibility endpoint was the percentage of patients who completed the study intervention. Of 20 patients allocated, 18 patients (90%, 95% CI: 68.3-98.8) completed the study intervention. A fast-track randomized controlled trial of CART for patients with malignant ascites is feasible.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
1. Patient who received chemotherapy, immunotherapy, hormonal therapy, or abdominal radiotherapy in the previous 28 days. 2. Patient who have systemic infections or abdominal infections. 3. Patient who generate fever >= 38 degree celsius. 4. Patient whose systolic blood pressure < 80mmHg. 5. Hemoglobine <6.0 mg/dL Creatinine >= 2.0ug/dL Total bilirubine >= 5.0mg/dL 6. Patient who have history of hepatic encephalopathy. 7. Patient who have cognitive inpairement. 8. Patient without any intravenous line. 9. Other reasons by which physicians judge they are ineligible.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of patients whose time to next paracentesis are evaluable.
- Secondary Outcome Measures
Name Time Method The period until ascites reaccumulation(e.g., Time to next paracentesis, paracentesis-free survival, abdominal distention relapse-free period, abdminal circumference rebound-free period, and paracentesis request-free period), intensity of ascites-related symptoms, and adverse events.