EUS-guided Response Assessment to NSBB

Not Applicable

Recruiting

• Conditions: Portal Hypertension Related to Cirrhosis

• Registration Number: NCT06513195
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-16
• Study Start: 2024-07-17
• Study First Posted: 2024-07-22
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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.

Exclusion Criteria

General criteria

• Patient is <18 or >80 years of age
• 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 cirrhosis and HCC Portopulmonary hypertension Portal or splanchnic venous thrombosis Prior TIPS Prior liver transplantation
• Non-cirrhotic portal hypertension or pre-sinusoidal liver disease
• Cholestatic liver disease with total bilirubin >3 mg/dl
• Previous total or partial splenectomy
• Known infection that is not controlled by medical intervention
• 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

• Patients with reduced life expectancy described by an ASA score of 4 or 5
• INR >1.7 or platelet count <50.000 per mm3
• eGFR <50 ml/min/1.73m2 (CKD-EPI formula) Anatomical criteria
• 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
• Diagnosis of portal vein thrombosis during EUS
• Evidence of active gastrointestinal bleeding during EUS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
EUS-guided response assessment to NSBB in the treatment of CSPH.	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.

Secondary Outcome Measures

Name	Time	Method
Correlation of PVP with WHVP.	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.
Correlation of EUS-PPG with HVPG	Three months	To assess the correlation of EUS-PPG and HVPG before treatment start as well as after treatment start with NSBB
CSPH assessed via EUS-guided pressure measurement.	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.
Safety of repeated EUS-PPG	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.
Correlation of FHVP with HVP.	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.
Correlation of sequential EUS-PPG and HVPG with non-invasive assessment tools before/after treatment with NSBB.	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).

Trial Locations

Locations (1)

University Hospital Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium