EUS-guided Response Assessment to NSBB
NCT Number: NCT06513195
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Portal Hypertension Related to Cirrhosis
Interventions: PROCEDURE: endoscopic ultrasound-guided portal pressure measurement
Sponsor: Universitaire Ziekenhuizen KU Leuven
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-17
Completion Date: 2026-07
Locations: University Hospital Leuven, Leuven, Vlaams-Brabant, 3000, Belgium

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). 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.

Primary Outcome Measures: 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., Three months
Secondary Outcome Measures: 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, 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., 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., 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., 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)., 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., 14 weeks