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EUS-guided Response Assessment to NSBB

ConditionPortal Hypertension Related to Cirrhosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • endoscopic ultrasound-guided portal pressure measurement

    Procedure/Surgery

    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.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: EUS-PPG before and after NSBBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Three months

Secondary outcomes

1

Correlation of EUS-PPG with HVPG

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

Time frame
Three months
2

Correlation of FHVP with HVP.

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.

Time frame
Three months
3

Correlation of PVP with WHVP.

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.

Time frame
Three months
4

CSPH assessed via EUS-guided pressure measurement.

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

Time frame
Three months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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