NCT06513195Recruiting
EUS-guided Response Assessment to NSBB
Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 8 Jul 2024
- Start date
- 17 Jul 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- High blood pressure
- NCT number
- NCT06513195
What you commit to
- Study type: Interventional
- Planned participants: 24
- From 17 Jul 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with cirrhosis and HCC Portopulmonary hypertension Portal or splanchnic venous thrombosis Prior TIPS Prior liver transplantation
- Previous total or partial splenectomy
- 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
Other illness
- Non-cirrhotic portal hypertension or pre-sinusoidal liver disease
- Known infection that is not controlled by medical intervention
- Diagnosis of portal vein thrombosis during EUS
- Evidence of active gastrointestinal bleeding during EUS
Lab values
- Cholestatic liver disease with total bilirubin \>3 mg/dl
- INR \>1.7 or platelet count \<50.000 per mm3
- eGFR \<50 ml/min/1.73m2 (CKD-EPI formula) Anatomical criteria
Age
- Patient is \<18 or \>80 years of age
Other
- General criteria
- 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 reduced life expectancy described by an ASA score of 4 or 5
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.