EUS-guided Response Assessment to NSBB

June 2, 2026 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EUS-PPG before and after NSBB
Patients will undergo EUS-PPG and HVPG before and after NSBB treatment and will thus serve as their own control.
Procedure: endoscopic ultrasound-guided portal pressure measurement
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Three months
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.
Three months
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.
Three months
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.
Three months
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).
Three months
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.
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Investigators

  • Principal Investigator: Schalk van der Merwe, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 16, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s67433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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