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:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07490405
Eligibility Criteria:
Inclusion Criteria:
1. Confirmed diagnosis of cirrhotic portal hypertension.
2. Endoscopic examination confirmed the presence of severe esophagogastric varices accompanied by acute bleeding. Rebleeding occurred after endoscopic variceal ligation (EVL) treatment..
3. Presence of hypersplenism causing significant thrombocytopenia and/or leukopenia.
4. Liver function Child-Pugh class A or B (score 7-9).
5. Age 18-75 years.
6. Patient provides written informed consent.
Exclusion Criteria:
1. Liver function Child-Pugh class C (score ≥10), or Model for End-Stage Liver Disease (MELD) score \>18.
2. Severe right heart failure or pulmonary hypertension.
3. Uncontrolled systemic infection or sepsis.
4. Polycystic liver disease, portal cavernous transformation, or portal vein thrombosis (affecting procedure or shunt creation).
5. Advanced hepatocellular carcinoma (beyond Milan criteria) or other uncontrolled malignancies.
6. Severe hepatic encephalopathy (West-Haven grade III-IV) unresponsive to medication.
7. Severe contrast agent allergy (affecting TIPS procedure).
8. Pregnancy or lactation.
9. Any severe non-hepatic disease with a life expectancy \<1 year.
10. Recent gastric and duodenal ulcers.
11. Inability to comply with follow-up or provide informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07490405
Study Brief:
Protocol Section:
NCT07490405