Evaluation of Direct Portal Pressure Measurement by Endoscopic Ultrasound in Advanced Chronic Liver Disease and Newly Diagnosed Clinically Significant Portal Hypertension (EVADIPP)

What this Trial Is About

Researchers are investigating a minimally invasive method called endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement to directly assess portal pressure in patients with advanced chronic liver disease and clinically significant portal hypertension (CSPH). This observational study aims to compare the performance of EUS-PPG with the traditional hepatic venous pressure gradient (HVPG) method in evaluating the hemodynamic response to non-selective beta blockers (NSBBs). The study also seeks to identify markers linked to treatment response and factors that might affect the accuracy of portal pressure measurements. Participants will undergo EUS-PPG and HVPG measurements at the start and after NSBB dose adjustments. Additional assessments include liver and spleen elastography and gut microbiota evaluation before and after NSBB treatment to identify predictors of hemodynamic response. A subgroup of patients will have portal pressure measured under different sedation levels to study the impact of sedation depth on measurement accuracy. Follow-up outpatient visits occur every 2 to 3 months to monitor clinical events related to portal hypertension. During the study, participants will have regular clinical evaluations, imaging, and laboratory tests to assess portal pressure changes and treatment effects. Researchers will track outcomes such as portal hypertension-related bleeding and liver complications like ascites and encephalopathy over 24 months. The main measure is the comparison of portal pressure gradients by EUS and HVPG before and after NSBB titration. Safety and clinical progress are monitored throughout the study, which lasts up to two years.

Direct Portal Pressure Measurement Via Endoscopic Ultrasound in Advanced Chronic Liver Disease (EVADIPP)