EUS-guided Response Assessment to NSBB
- Conditions
- Portal Hypertension Related to Cirrhosis
- Interventions
- Procedure: endoscopic ultrasound-guided portal pressure measurement
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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.
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
- Arm && Interventions
Group Intervention Description EUS-PPG before and after NSBB endoscopic ultrasound-guided portal pressure measurement Patients will undergo EUS-PPG and HVPG before and after NSBB treatment and will thus serve as their own control.
- 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