University Hospital Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
NCT Number: NCT06513195
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
General criteria
Systolic BP <100 mmHg HR <50 bpm
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.
Other names: EUS-PPG
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.
Time frame: Three months
To assess the correlation of EUS-PPG and HVPG before treatment start as well as after treatment start with NSBB
Time frame: Three months
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
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
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
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).
Time frame: 14 weeks
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.
Contact information is provided by the study sponsor or research team.
Emma Vanderschueren, MD
CONTACT
Petra Windmolders
CONTACT
Universitaire Ziekenhuizen KU Leuven
Other
Endoscopic Ultrasound Guided Response Assessment to Non-selective Beta-blockers in the Treatment of Clinically Significant Portal Hypertension
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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