Actively Recruiting
Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-06-03
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether endoscopic ultrasound (EUS)-guided portal pressure measurement can help determine how patients with cirrhosis and clinically significant portal hypertension (CSPH) respond to treatment with non-selective beta-blockers (NSBB). This study pairs EUS measurements with transjugular hepatic venous pressure gradient (HVPG) and non-invasive tests to assess portal hypertension before starting NSBB therapy and after three months of treatment. Participants will undergo EUS-guided portal pressure measurements and HVPG both before and after receiving NSBB treatment, specifically Carvedilol. These measurements will be used to compare the changes in portal pressure and assess treatment response. Participants serve as their own control, with no additional treatment groups involved. During the study, participants will have pressure measurements taken at the start and after three months of NSBB therapy along with assessments using non-invasive tools. Safety of repeated EUS-guided pressure measurements will be monitored over 14 weeks. The main outcome measured is the response to NSBB treatment assessed by EUS-guided portal pressure after three months. Other outcomes include correlations between different pressure measurement methods, assessment of portal hypertension, and safety monitoring.
CONDITIONS
Brief Title
EUS-guided Response Assessment to NSBB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a clinical and/or pathological diagnosis of compensated cirrhosis
- Patients with suspicion of clinically significant portal hypertension and indication for non-selective beta-blocker treatment
- Patients not yet on non-selective beta-blocker therapy
- Patients willing and able to undergo repeated hepatic venous pressure gradient and endoscopic ultrasound-guided pressure measurements as per protocol
You will not qualify if you...
- Age under 18 or over 80 years
- Pregnant, breast-feeding, or planning pregnancy during the study
- Unwilling or unable to sign informed consent
- Contraindications for general anesthesia or endoscopic procedures
- Cirrhosis with hepatocellular carcinoma
- Portopulmonary hypertension
- Portal or splanchnic venous thrombosis
- Prior transjugular intrahepatic portosystemic shunt (TIPS) or liver transplantation
- Non-cirrhotic portal hypertension or pre-sinusoidal liver disease
- Cholestatic liver disease with total bilirubin over 3 mg/dl
- Previous total or partial splenectomy
- Uncontrolled infection
- Contraindications to non-selective beta-blocker therapy, including systolic blood pressure under 100 mmHg or heart rate under 50 bpm
- Reduced life expectancy with ASA score of 4 or 5
- INR over 1.7 or platelet count under 50,000 per mm3
- Estimated glomerular filtration rate under 50 ml/min/1.73m2
- Anatomical abnormalities preventing endoscopic ultrasound-guided puncture access
- Ascites blocking puncture tract on endoscopic ultrasound
- Portal vein thrombosis diagnosed during endoscopic ultrasound
- Active gastrointestinal bleeding during endoscopic ultrasound
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 months
Participants undergo endoscopic ultrasound-guided portal pressure measurements before and after treatment with non-selective beta-blockers to assess portal hypertension.
2 visits (in-person) for pressure measurements before and after treatment
Trial Site Locations
Total: 1 location
1
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
E
Emma Vanderschueren, MD
P
Petra Windmolders
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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