Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06266260
Study type Observational
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Francesco Santopaolo, MD
Phone +393492754288
Email francesco.santopaolo@policlinicogemelli.it
Status Recruiting
Phase
Start date September 11, 2023
Completion date April 1, 2026

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05052892 - A Novel Spleen-dedicated Stiffness Measured by FibroScan to Evaluate Cirrhotic Portal Hypertension (CHESS2105)
Recruiting NCT05251272 - A Combined Model Based on Spleen Stiffness, Liver Stiffness and Platelets for Assessing Portal Hypertension in Compensated Cirrhosis (CHESS2202)
Recruiting NCT05928624 - A Pilot Trial to Test the Feasibility of Utilizing Home Blood Pressure Monitoring to Optimize the Administration of Midodrine Among Decompensated Cirrhosis Patients N/A
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting NCT05515861 - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices N/A
Recruiting NCT02364297 - TIPS in Fundal Variceal Bleeding (the TFB Study) N/A
Recruiting NCT01358123 - Value of Von Willebrand Factor in Portal Hypertension N/A
Completed NCT00493480 - Danish Carvedilol Study in Portal Hypertension Phase 3
Recruiting NCT03277651 - Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension N/A
Active, not recruiting NCT03736265 - Carvedilol for Prevention of Esophageal Varices Progression N/A
Completed NCT03451149 - Feasibility And Safety Of Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation Using A Radiofrequency Guidewire N/A
Completed NCT02994485 - Evaluation Of The Portal Pressure By Doppler Ultrasound In Cirrhotic Patients Before And After Simvastatin Phase 4
Completed NCT01851252 - MBT Versus HVPG in Identifying Responders to Portal Hypertension Therapy Phase 1
Completed NCT01923064 - Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices N/A
Completed NCT01551966 - Esophageal Capsule Endoscopy in Children N/A
Completed NCT01456286 - Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension Phase 2/Phase 3
Completed NCT02344719 - Effect of Taurine on Portal Hemodynamics in Patients With Advanced Liver Cirrhosis Phase 4
Recruiting NCT00414713 - Transfusion Requirements in Gastrointestinal (GI) Bleeding Phase 4
Completed NCT00766805 - Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis N/A
Recruiting NCT06434753 - Zinc Supplementation to Improve Prognosis in Patients With Compensated Advanced Chronic Liver Disease. Phase 3