Clinical trial NCT06266260: Direct Portal Pressure Measurement Via Endoscopic Ultrasound in Advanced Chronic Liver Disease (EVADIPP)
Official title: Evaluation of Direct Portal Pressure Measurement by Endoscopic Ultrasound in Advanced Chronic Liver Disease and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Portal Hypertension
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive outpatients with newly diagnosed esophago-gastric varices or with high suspicion of CSPH at non-invasive tests, naïve to treatment with NSBBs, will be evaluated over a two-years period.

Brief summary: A minimally invasive procedure to directly assess portal pressure gradient under endoscopic ultrasound guidance (EUS-PPG) has become available and initial data have proved the technique to be safe. Aims of our proposal are: (i) to assess performance of EUS-PPG as compared to HVPG in evaluating hemodynamic response to non selective betablockers (NSBBs) in a large cohort of patients with CSPH;(ii) identification of markers of hemodynamic response(iii) identification of factors potentially affecting the accuracy of PPG measurement.

Detailed description: Specific Aim 1 To explore the correlation between endoscopic ultrasound (EUS)-guided portal pressure gradient (PPG) and hepatic venous pressure gradient (HVPG) in evaluation of hemodynamic response to non-selective beta blockers (NSBBs) in patients with advanced chronic liver disease and high risk varices. The investigators will perform EUS-PPG measurement and HVPG measurement at baseline and after NSBBs titration in enrolled patients. Hemodynamic response to medical therapy is defined as either a decrease in HVPG by \>20% of the baseline value or an absolute value of HVPG \< 12 mmHg after dose titration.

Correlation between PPG/HVPG values and development of portal hypertension-related gastrointestinal bleeding or liver- related events (ascites, spontaneous bacterial peritonitis, and hepatic encephalopathy) will be clinically assessed during follow-up with outpatients visits every 2-3 months.

Specific Aim 2 Identification of other markers of hemodynamic response to non selective beta blockers (NSBBs), with focus on elastography modifications and gut microbiota composition. To identify predictors of hemodynamic response, splenic and hepatic elastography measurement will performed at baseline and after NSBBs titration. In the same way the investigators will evaluate the gut microbiota before and after the start of therapy with NSBBs.

Specific Aim 3 Identification of factors potentially affecting the accuracy of PPG measurement. It is well-known that deep sedation may cause inaccurate HVPG values, while mild sedation with low dose midazolam does not modify the HVPG. In a subgroup of enrolled patients the investigators will perform PPG measurement with deep and mild sedation in order to investigate influence of deep sedation on PPG measurement accuracy.

Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed esophago-gastric varices or with high suspicion of CSPH at non-invasive tests (porto- systemic collaterals at imaging, platelet count \<150.000 x mm3, spleen size \>13 cm in the largest axis, alteration of elastography parameters of the liver or spleen)
* naïve to treatment with NSBBs,

Exclusion Criteria:

* Child Pugh \>A6
* Hepatocellular carcinoma
* Portal vein thrombosis

Primary outcomes:
measure: Measurement of the portal pressure gradient though endoscopic ultrasound (EUS) and hepatic venous pressure gradient (HVPG) to evaluate the hemodynamic response to non-selective beta blockers (NSBBs)
timeFrame: 24 months
measure: HVPG Measurement Before and After NSBB Titration in Portal Hypertension
timeFrame: 24 months
Secondary outcomes:
measure: Markers of hemodynamic response
timeFrame: 24 months
measure: Identifying Markers of Hemodynamic Response in Portal Hypertension
timeFrame: 24 months
measure: Clinical and Biochemical Indicators of Hemodynamic Response
timeFrame: 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli IRCCS, Rome
name: Francesco Santopaolo, MD
role: PRINCIPAL_INVESTIGATOR
References: