Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-27 @ 1:25 PM
Study NCT ID:
NCT06266260
Status:
RECRUITING
Last Update Posted:
2025-03-14
First Post:
2023-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Portal Pressure Measurement Via Endoscopic Ultrasound in Advanced Chronic Liver Disease (EVADIPP)
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
Evaluation of Direct Portal Pressure Measurement by Endoscopic Ultrasound in Advanced Chronic Liver Disease and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVADIPP
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: