Evaluation of the Efficacy and Safety of Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS) in the Therapeutic Algorithm of Patients with Liver Cirrhosis.

Condition(s) studied

Study summary

The development of Clinical significant PH (CSPH) is a major driver of complications. PPG is the strongest predictor of decompensation . The shortcomings of GPVH measurements and invasiveness has resulted in an area of unmet clinical need. Non-selective beta-blockers (NSBB) have demonstrated efficacy in reducing PH. However, this requires a second invasive procedure, and there is high interindividual variability in the hemodynamic response to NSBB. EUS-guided GPP measurement emerges as a more accurate, accessible and less invasive technique to potentially predict chronic hemodynamic response. The aim of this project is to assess the safety and efficacy of EUS-derived GPP measurement (EUS-GPP) in patients diagnosed with cirrhosis, to assess the acute hemodynamic response through EUS-derived GPP to intravenous propranolol administration in order to determine the patients who would benefit from NSBB treatment in primary prophylaxis to prevent decompensation using a strategy guided by EUS-GPP measurement.

Eligibility

Primary outcome measure(s)

• - Endoscopic ultrasound with determination of the portal venous pressure gradient using a 25G needle with adapted — 12 months
  The portal pressure gradient (PPG) is obtained via transgastric, ultrasound-guided intraparenchymal hepatic puncture using a 25G needle (EchoTip Insight, Cook Medical®) equipped with a pressure gauge. Measurements are obtained in mm Hg. A puncture is made in the middle hepatic vein, and three pressure determinations are taken, each lasting one minute. The lowest observed pressure is recorded, and the mean is calculated. Subsequently, the left branch of the portal vein is punctured, and three measurements are taken, each lasting one minute, and their mean is calculated. The PPG is obtained by subtracting the mean pressures in the portal vein from the mean pressures in the hepatic vein. The pressure gauge recording the pressures is always fixed in the same position for all pressure measurements, positioned at the level of the patient's venous axis. After the initial hemodynamic assessment, propranolol (0.15 mg/kg of body weight; aqueous solution of propranolol hydrochloride \[1 mg/ml\] st

Trial sites (1)

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