Portal Hypertension Related to CirrhosisNCT06513195
EUS-guided Response Assessment to NSBB
A study testing endoscopic ultrasound-guided portal pressure measurement in people with Portal Hypertension Related to Cirrhosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Portal Hypertension Related to Cirrhosis
- What is being tested?
- endoscopic ultrasound-guided portal pressure measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Jul 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven, Vlaams-Brabant, 3000
Emma Vanderschueren, MD, 000-000-0000 ext. 003216349518, emma.vanderschueren@uzleuven.be
About this study
Official title: 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.
- Conditions
- Portal Hypertension Related to Cirrhosis
- Being tested
- endoscopic ultrasound-guided portal pressure measurement
- Keywords
- portal hypertension, EUS-PPG, HVPG, cirrhosis, non-selective beta blockers
- Medical subject headings
- Hypertension, Portal, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic ultrasound-guided portal pressure measurementProcedure or surgery
Also called EUS-PPG
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.
| Study group | Role | What they receive |
|---|---|---|
| EUS-PPG before and after NSBB | Experimental | Patients will undergo EUS-PPG and HVPG before and after NSBB treatment and will thus serve as their own control. Receives: Procedure: endoscopic ultrasound-guided portal pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months
Secondary outcomes (6)
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
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
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.
Measured: Three months
Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB.
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).
Measured: Three months
Safety of repeated EUS-PPG
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start17 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Hypertension Related to CirrhosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Schalk van der Merwe, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513195
- Sponsor's protocol ID
- s67433
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension
- ClinicalTrials.gov ID
- NCT06513195
- Acronym / sponsor ID
- s67433
- Conditions
- Portal Hypertension Related to Cirrhosis
- Keywords
- portal hypertension, EUS-PPG, HVPG, cirrhosis, non-selective beta blockers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 17 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-PPG before and after NSBB | Experimental | Procedure: endoscopic ultrasound-guided portal pressure measurementPatients will undergo EUS-PPG and HVPG before and after NSBB treatment and will thus serve as their own control. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic ultrasound-guided portal pressure measurementAlso: EUS-PPGThe 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. | Procedure or surgery | EUS-PPG before and after NSBB |
Primary outcome
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.
6 secondary outcomes
Correlation of EUS-PPG with HVPG
Time frame: Three months
Correlation of FHVP with HVP.
Time frame: Three months
Correlation of PVP with WHVP.
Time frame: Three months
CSPH assessed via EUS-guided pressure measurement.
Time frame: Three months
Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB.
Time frame: Three months
Safety of repeated EUS-PPG
Time frame: 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No. Patient confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Schalk van der Merwe, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic ultrasound-guided portal pressure measurement in people with Portal Hypertension Related to Cirrhosis, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Vanderschueren, MD (0032 16 345918, emma.vanderschueren@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EUS-guided response assessment to NSBB in the treatment of CSPH. (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.