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EUS-guided Response Assessment to NSBB

EUS-guided Response Assessment to NSBB

Recruiting
18-80 years
All
Phase N/A

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Overview

The goal of this clinical trial is to learn if endoscopic ultrasound (EUS)-guided portal pressure measurement can determine the treatment response to non-selective beta-blockers (NSBB) in patients with cirrhosis and clinically significant portal hypertension (CSPH). Participants will undergo EUS-guided portal pressure measurement before start of Carvedilol en after three months of treatment. EUS-guided measurements will be paired with transjugular hepatic venous pressure gradient (HVPG) measurement as well as non-invasive tests for assessment of portal hypertension.

Eligibility

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

Study details
    Portal Hypertension Related to Cirrhosis

NCT06513195

Universitaire Ziekenhuizen KU Leuven

30 August 2025

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