malignant disease refractory ascites
Conditions
Interventions
1. Drain insertion for peritoneal cavity and discarding ascites
A drain is inserted into the peritoneal cavity under US guidance using the Seldinger technique at the interventional radiological suite.
ascites drainage, nasogastric tube insertion, infusion of ascites into the gastrointestinal tract
Sponsors
Shunsuke Sugawara
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Any cancer can be included. 2. Extension and degree of the disease The patient has refractory symptomatic ascites. The patients have received ascites drainage for palliation within 1 month, and the symptom recurred within 2 weeks after the ascites drainage. Malignant cells (class IV/V) have been detected from the cytology of the ascites. Any curative treatment (e.g., surgery or ablation therapy) can not be indicated. Any stage of the disease can be included. 3. age The age of the patient is 20 y.o. or older and 80 y.o. or younger. 4. PS (Performance status) ECOG performance status score is 2 or lower. When the PS deteriorated 3 or lower by large amount of ascites, the PS is evaluated based on the condition which is expected after ascites drainage. 5. Measurability of the lesion The existence of the measurable lesion is not required because the population of the target of this study is refractory ascites. 6. Regulation for pretreatment There is no regulation for pretreatment including chemotherapy and radiation therapy for present and any other disease. 7. Function of organs (laboratory data) Platelet counts are 50,000/dl or higher PT-INR is below 1.5 Total bilirubin level is 1.5mg/dl or lower eGFR is higher than 30ml/min. 8. Informed consent is obtained from the patient.
Exclusion criteria
Exclusion criteria: 1. No history of ascites drainage. 2. Bloody ascites. 3. Ascites with high viscosity. 4. It is expected that effective drainage cannot be obtained by a single drain due to adhesion in the peritoneal cavity. 5. Insertion of a nasogastric tube, gastrostomy, or PTEG is impossible. 6. The patient is suffering from active infectious disease (e.g., infectious peritonitis). 7. Symptomatic heart failure (NYHA II=>). 8. Symptomatic respiratory failure (SpO2 is lower than 90% under the room air). 9. Hyperammonemia (67mcg/dl or higher). 10. The antithrombotic drug is used which cannot be ceased. 11. The patient has symptoms or imaging findings of bowel obstruction. 12. There are other reasons that the doctor considers the patients should not be included in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric rating scale of abdominal distention, body weight, abdominal girth, serum albumin level, number of defecation, and characteristics of the stool. | — |
Contacts
Public ContactSugawara Shunsuke
National Cancer Center Hospital
Outcome results
None listed