EUS-guided Response Assessment to NSBB

Universitaire Ziekenhuizen KU Leuven24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Portal Hypertension Related to Cirrhosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Three months

Secondary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 14 weeks

EUS-guided Response Assessment to NSBB

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts