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 @ 2:21 PM
Ignite Modification Date:
2025-12-24 @ 2:21 PM
NCT ID:
NCT06513195
Eligibility Criteria:
Inclusion Criteria:
* Patients with a clinical and/or pathological diagnosis of compensated cirrhosis.
* Patients with suspicion of CSPH and thus indication for NSBB treatment.
* Patients not yet on NSBB therapy.
* Patients willing and able to undergo repeated HVPG and EUS-guided pressure measurements as per protocol.
Exclusion Criteria:
General criteria
* Patient is \<18 or \>80 years of age
* Patient is pregnant, breast-feeding or planning to become pregnant during the course of the study
* Patient is unwilling or unable to sign the informed consent
* Patients in whom general anesthesia or endoscopic procedures are contraindicated Medical criteria
* Patients with cirrhosis and HCC Portopulmonary hypertension Portal or splanchnic venous thrombosis Prior TIPS Prior liver transplantation
* Non-cirrhotic portal hypertension or pre-sinusoidal liver disease
* Cholestatic liver disease with total bilirubin \>3 mg/dl
* Previous total or partial splenectomy
* Known infection that is not controlled by medical intervention
* Patients with contraindications for non-selective beta-blocker therapy, including but not limited to the following baseline vital signs:
Systolic BP \<100 mmHg HR \<50 bpm
* Patients with reduced life expectancy described by an ASA score of 4 or 5
* INR \>1.7 or platelet count \<50.000 per mm3
* eGFR \<50 ml/min/1.73m2 (CKD-EPI formula) Anatomical criteria
* Anatomical abnormalities that prevent access via EUS-guided puncture to the hepatic vein or intrahepatic portion of the portal vein, including anatomy that predisposes to difficult to reach puncture sites or an inadequate needle angle.
* Visualization of ascites interposing the puncture tract on EUS
* Diagnosis of portal vein thrombosis during EUS
* Evidence of active gastrointestinal bleeding during EUS
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06513195
Study Brief:
Protocol Section:
NCT06513195