malignant ascites
Conditions
Interventions
In this fast-track RCT, patients are randomised either to an intervention group, where they receive concentrated ascites reinfusion therapy(CART), or the control group, whrer they receive paracentesis
Sponsors
Seirei Hospice, Seirei Mikatahara General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Metastatic or locally advanced cancer patients diagnosed either pathologically or clinically. 2. Life expectancy >= 14 days 3. Hospitalized in Seirei Hospice 4. At least one symptomatic paracentesis within 3 weeks as well as an objectively verified, clinical need for a second paracentesis. 5. Refractory or resistant to chemotherapy, or standard chemotherapy is no longer feasible. 6. Patients who are fluent in Japanese. 7. Concent to this trial.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of patients whose time to next paracentesis are evaluable. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactNaosuke Yokomichi
Seirei Mikatahara General Hospital Seirei Hospice
Outcome results
None listed