Actively Recruiting
EUS-guided Response Assessment to NSBB
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-26
24
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 (CSPH) and indication for NSBB treatment
- Patients not yet on non-selective beta-blocker therapy
- Patients willing and able to undergo repeated HVPG and EUS-guided pressure measurements as per protocol
You will not qualify if you...
- Age less than 18 or greater than 80 years
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Unwilling or unable to provide informed consent
- Contraindications to general anesthesia or endoscopic procedures
- Presence of cirrhosis with hepatocellular carcinoma (HCC), portopulmonary hypertension, portal or splanchnic venous thrombosis, prior TIPS, or prior liver transplantation
- Non-cirrhotic portal hypertension or pre-sinusoidal liver disease
- Cholestatic liver disease with total bilirubin greater than 3 mg/dl
- Previous total or partial splenectomy
- Known uncontrolled infection
- Contraindications to non-selective beta-blocker therapy including systolic blood pressure below 100 mmHg or heart rate below 50 bpm
- Reduced life expectancy with ASA score of 4 or 5
- INR greater than 1.7 or platelet count below 50,000 per mm3
- eGFR below 50 ml/min/1.73m2 (CKD-EPI formula)
- Anatomical abnormalities preventing EUS-guided access to hepatic or portal veins
- Visualization of ascites blocking EUS puncture path
- Diagnosis of portal vein thrombosis during EUS
- Evidence of active gastrointestinal bleeding during EUS
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
E
Emma Vanderschueren, MD
CONTACT
P
Petra Windmolders
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here