Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-25 @ 3:00 AM
NCT ID:
NCT05745233
Eligibility Criteria:
Inclusion Criteria:
* Patients have cyto-/histologically confirmed malignant ascites from gastric, pancreatic or biliary tract adenocarcinoma
* Patients have malignant ascites more than 1000ml
* Patients have no history of prior intraperitoneal therapy for malignant ascites
* Patients have life expectancy of at least 4 weeks
* Patients have adequate platelet count ≥ 50,000/ul
* Women or men of reproductive potential should agree to use an effective contraceptive method
* All patients must be informed of the investigational nature of this study and must sign written informed consents.
Exclusion Criteria:
* Patients have ascites which is related to causes other than the malignancies
* Patients who are receiving intraperitoneal treatment for their malignant ascites including therapeutic paracentesis
* Patients with active infection
* Patients with bleeding disorders
* Patient with active cardiopulmonary disease or history of ischemic heart disease
* Patients have intolerant abdominal pain
* Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT05745233
Study Brief:
Protocol Section:
NCT05745233