This study will be used to train an algorithm using Methacetin breath test (MBT) measures and to select a cut-off to determine presence or absence of Clinically Significant Portal Hypertension (CSPH) as defined by Hepatic Venous Gradient Pressure (HVPG) ≥ 10mmHg,
The portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
246
13C labelled methacetin solution for breath test monitoring
VA Connecticut HealthCare System
New Haven, Connecticut, United States
Duke University Medical Center
Durham, North Carolina, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Hôpital Beaujon
Paris, France
CSPH (Clinically Significant Portal Hypertension)
Clinically significant portal hypertension is defined as Hepatic Venous Pressure Gradient (HVPG)\>=10mmHg, whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.
Time frame: 1 hour
Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)
Hepatic Venous Pressure Gradient greater than 12 (SPH) is an indicator of bleeding varices. whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify SPH and the agreement to the reference standard (HVPG) will be assessed in this study.
Time frame: 1 hour
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Hopital Purpan
Toulouse, France
(University of Barcelona) Hospital Clinic
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Inselspital
Bern, Switzerland