Safety confirmation study for peritoneo-gastrointestinal shunt creatio

Phase 1

Recruiting

• Conditions: malignant disease; refractory ascites

• Registration Number: JPRN-jRCT1032220387
• Lead Sponsor: Shunsuke Sugawara

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 9

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
umeric rating scale of abdominal distention, body weight, abdominal girth, serum albumin level, number of defecation, and characteristics of the stool.