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ID06266260

Measuring Portal Pressure Using Endoscopic Ultrasound in Advanced Liver Disease to Evaluate Response to Beta Blockers

Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-14

50

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

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.

CONDITIONS

Brief Title

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

Research Team

F

Francesco Santopaolo, MD

E

Elisabetta Creta, SC

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