Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266260
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2023-09-11
Brief Title:
Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension EVADIPP
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Evaluation of the Performance of Direct Portal Pressure Measurement by Endoscopic Ultrasound in a Large Cohort of Patients With Advanced Chronic Liver Disease of Different Etiologies and Newly Diagnosed Clinically Significant Portal Hypertension EVADIPP
Status:
RECRUITING
Status Verified Date:
2024-02
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 CSPHii identification of markers of hemodynamic responseiii 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 PPGHVPG 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 PPGHVPG 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:
None
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?:
None