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:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT07172035
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 80 years old;
2. Diagnosed with decompensated liver cirrhosis (diagnostic criteria: positive liver histopathological examination, or comprehensive judgment based on clinical symptoms, biochemical indicators and imaging features);
3. The etiology of liver cirrhosis is intervenable (including hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, alcoholic liver disease (ALD), etc.);
4. Patients with indications for Transjugular Intrahepatic Portosystemic Shunt (TIPS) treatment of cirrhotic portal hypertension, such as those with cirrhotic portal hypertension-related esophagogastric variceal bleeding refractory to endoscopic treatment, and patients with refractory ascites caused by cirrhotic portal hypertension;
5. Obtained informed consent signed by the patient or their family members.
Exclusion Criteria:
1. Compensated liver cirrhosis at the time of TIPS treatment (without decompensated events such as ascites, hepatic encephalopathy, or esophagogastric variceal bleeding);
2. TIPS performed for the treatment of non-cirrhotic portal hypertension (e.g., idiopathic portal hypertension, Budd-Chiari syndrome, sinusoidal obstruction syndrome, etc.);
3. Patients complicated with malignant tumors such as hepatocellular carcinoma (HCC), renal cell carcinoma, or lung cancer prior to TIPS;
4. Patients with severe cardiopulmonary dysfunction or a Model for End-Stage Liver Disease (MELD) score \> 18;
5. Pregnant patients;
6. Patients with uncontrolled systemic infection or inflammation;
7. Patients with severe coagulation disorders;
8. Patients allergic to contrast medium.
Criteria for Termination/Withdrawal from the Study:
1. Patients with Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure failure due to various reasons;
2. Patients who voluntarily request to withdraw from the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07172035
Study Brief:
Protocol Section:
NCT07172035