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 @ 6:34 PM
Ignite Modification Date:
2025-12-24 @ 6:34 PM
NCT ID:
NCT05719857
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years;
* Patients with specific signs of portal hypertension:
1. Endoscopic: esophagogastric/ectopic varices;
2. On imaging (US, CT or MRI): portosystemic collateral veins;
* Transient hepatic elastography with valid values ≤ 20 kPa;
* Signed written informed consent form.
Exclusion Criteria:
* Contraindications to HVPG or percutaneous liver biopsy:
1. Pregnancy
2. Allergy to iodine
3. Chronic kidney disease with creatinine clearance \< 50 ml/min
4. Anticoagulation
5. RNI \> 1.5
6. Platelets \< 50,000/mm3
* Confounding factors:
1\. Hepatitis C treated with SVR
* Conditions that exclude the diagnosis of PSVD:
1. History of bone marrow transplant
2. Budd-Chiari
3. Congestive heart failure or Fontan surgery
4. Abernethy's Syndrome
5. Hereditary hemorrhagic telangiectasia
6. Chronic cholestatic diseases
7. Neoplastic hepatic infiltration
8. Sarcoidosis
9. Congenital hepatic fibrosis
10. Hepatosplenic schistosomiasis
11. Portal cavernoma / thrombosis with complete occlusion of the main portal vein.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05719857
Study Brief:
Protocol Section:
NCT05719857