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

Shunsuke Sugawara0 sites9 target enrollmentOctober 18, 2022

Overview

No summary available.

Registry

who.int

Start Date

October 18, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Shunsuke Sugawara

•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

•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.