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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS-PPG before and after NSBB | Experimental | Patients will undergo EUS-PPG and HVPG before and after NSBB treatment and will thus serve as their own control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic ultrasound-guided portal pressure measurement | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
General criteria
Systolic BP <100 mmHg HR <50 bpm
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Vanderschueren, MD | Contact | 0032 16 345918 | emma.vanderschueren@uzleuven.be | |
| Petra Windmolders | Contact | 003216 347581 | petra.windmolders@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Schalk van der Merwe, MD, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Leuven | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
Patient confidentiality
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |