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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT04198259
Eligibility Criteria:
Inclusion Criteria:
* Liver cirrhosis diagnosed by clinical examination, imaging or biopsy
* Patients with a previous history of variceal hemorrhage
* Gastric variceal confirmed by an endoscopic examination, including IGV1 or IGV2
* Aged 18 to 75 years
* Adequate liver and kidney function, including Child-Turcotte-Pugh score \< 12, MELD score \<19, and serum creatinine less than 2 times the upper limit of normal.
Exclusion Criteria:
* Active variceal bleeding
* Esophageal variceal, including GOV1 or GOV2 type, mainly esophageal varices;
* Refractory ascites
* Patients with contraindication to treatment of TIPS, including congestive heart failure, NYHA III and IV, pulmonary arterial hypertension(\>50mmHg), polycystic liver, intrahepatic duct dilatation, spontaneous bacterial peritonitis, hepatic encephalopathy
* Patients with contraindication to treatment of Carvedilol, including asthma, insulin-dependent diabetes, peripheral vascular diseases
* Child-Turcotte-Pugh score \>=12, or MELD score \>=19
* Budd-Chiari syndrome
* The main portal vein thrombosis is greater than 50%
* Malignancies
* An uncontrolled infection
* Previously treated with TIPS, splenectomy pericardia vascular disconnection, or surgical shunts
* HIV or HIV related illness
* Allergic to contrast agent
* Lactating or pregnant
* Non-compliant patients
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04198259
Study Brief:
Protocol Section:
NCT04198259