Surrogate Markers of Portal Pressure

NACompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

July 31, 2018

Study Completion Date

July 31, 2019

Conditions
Portal HypertensionCirrhosis
Interventions
PROCEDURE

HVPG

HVPG will be performed by placing a placing a 7F venous catheter into a supra-hepatic vein and then advancing a 5F balloon-tipped catheter into the right hepatic vein. Wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP) will be measured by connection to an external transducer and polygraph (PowerLab, ADInstruments Inc., Colorado Springs, CO). After inflating the balloon catheter, adequacy of the occlusion will be established by injection of a small amount of radiologic contrast medium. Hepatic Venous Pressure gradient (HVPG) will be calculated as the difference between WHVP and FHVP.

DRUG

Indocyanine Green Retention test

As decribed in arm descriptions

DEVICE

Liver stiffness measurement

As decribed in arm descriptions; perfromed by ARFI

DEVICE

Spleen stiffness measurement

As decribed in arm descriptions; performed by ARFI

Trial Locations (2)

06511

Yale-New Haven Hospital, New Haven

06516

VA Connecticut Healthcare System, West Haven

All Listed Sponsors
lead

VA Connecticut Healthcare System

FED

NCT02508298 - Surrogate Markers of Portal Pressure | Biotech Hunter | Biotech Hunter