Safety confirmation study for peritoneo-gastrointestinal shunt creation for refractory ascites

Shunsuke Sugawara0 个研究点目标入组 9 人开始时间: 2022年10月18日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.
•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.

•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.

发起方

Shunsuke Sugawara