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NCT Number: NCT06513195

EUS-guided Response Assessment to NSBB

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Location contact

Emma Vanderschueren, MD

CONTACT

[email protected]

000-000-0000 ext. 003216349518

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endoscopic ultrasound-guided portal pressure measurement

Procedure

The portal pressure gradient will be determined by endoscopic ultrasound-guided pressure measurement in the hepatic vein and the portal vein. The gradient will be calculated by substracting the hepatic vein pressure from the portal vein pressure.

Other names: EUS-PPG

Primary outcomes

  1. EUS-guided response assessment to NSBB in the treatment of CSPH.

    Time frame: Three months

    To assess if a positive response to non-selective beta-blockers (NSBB) treatment, as determined by a reduction of 10% or more in the hepatic venous pressure gradient (HVPG) and/or a decrease to values less than 12 mmHg, can be similarly observed using endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement.

Secondary outcomes

  1. Correlation of EUS-PPG with HVPG

    Time frame: Three months

    To assess the correlation of EUS-PPG and HVPG before treatment start as well as after treatment start with NSBB

  2. Correlation of FHVP with HVP.

    Time frame: Three months

    To assess the correlation of EUS-guided hepatic venous pressure (HVP) and transjugular free hepatic venous pressure (FHVP) measurement before treatment start as well as after treatment start with NSBB.

  3. Correlation of PVP with WHVP.

    Time frame: Three months

    To assess the correlation of EUS-guided portal venous pressure (PVP) and transjugular wedged hepatic venous pressure (WHVP) measurement before treatment start as well as after treatment start with NSBB.

  4. CSPH assessed via EUS-guided pressure measurement.

    Time frame: Three months

    To determine if the current definition of CSPH (i.e. HVPG >/= 10 mmHg) can be adopted for portal tension measurement via EUS-PPG.

  5. Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB.

    Time frame: Three months

    To evaluate the correlation of sequential PPG and HVPG measurements, before and after treatment start with NSBB, with (the evolution of) non-invasive assessment tools. Non-invasive tools evaluated are fibrosis-4 (FIB-4) score, AST to platelet ratio index (APRI), liver stiffness-spleen size-to-platelet ratio-score (LSPS), platelet count to spleen diameter ratio (PSR), liver stiffness measurement (LSM) and spleen stiffness measurement (SSM).

  6. Safety of repeated EUS-PPG

    Time frame: 14 weeks

    To assess the number of participants with any adverse event related to the (repeated) EUS-guided portal pressure gradient measurements. Potential risks associated with the study-specific intervention include fever, (minor) haemorrhage, (minor) infection, inflammation, pain/discomfort, (minor) vessel trauma, vessel occlusion/thrombosis, allergic reaction to medication*, aspiration*, cardiac arrhythmia or arrest*, respiratory depression or arrest*, death*. Adverse events indicated with * are related to the gastrointestinal endoscopic procedure required for the EUS-PPG intervention and are not specific to the device.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Vanderschueren, MD

CONTACT

[email protected]

0032 16 345918

Petra Windmolders

CONTACT

[email protected]

003216 347581

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2024
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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