Quantitative Liver Function Tests Using Cholates

Status Active, not recruiting

Clinical Trial Summary

As the treatments for liver disease and the availability of liver transplantation have progressed, the number of patients with end stage liver disease continues to increase. This has increased the need to risk-stratify patients with cirrhosis to better direct their treatments and provide an accurate prognosis for their outcomes. The traditional assessment of the liver patient has been limited to imaging, static measures of "liver function tests" and liver biopsy. This protocol is designed to increase the spectrum of tests in the evaluation of the patient with end stage liver disease.

Clinical Trial Description

This study involves using the dual cholate test as our quantitative liver function test of choice. Clearance of the oral cholate provides an assessment of portal blood flow. Clearance of the intravenous (IV) cholate provides an assessment of the systemic blood flow. The ratio of these clearances indicates the fraction of cholate that is shunted to the systemic circulation, and is called the cholate shunt fraction.2 This study will measure cholate elimination rate constant (cholate Kelim), clearance of orally administered cholate, clearance of intravenously administered cholate and cholate shunt. This study will compare the presence and extent of the cholate clearances and shunt fraction with the presence and extent of hepatic fibrosis and portal hypertension (as measured by a hepatic venous pressure gradient [HVPG] procedure.) The patients who will be enrolled in this study may or may not be those who are undergoing clinically indicated hepatic venous pressure gradient (HVPG) measurements at Baylor University Medical Center, with or without a liver biopsy. Patients having the HVPG measurements will be admitted to Baylor University Medical Center (BUMC) and prepared in the routine clinical fashion for their clinically-indicated HVPG measurement. The cholate test, including blood draws, will be performed after the HVPG procedure. The cholate test may also be performed in the Hepatology clinic ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01907074
Study type	Interventional
Source	Baylor Research Institute
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	July 2011
Completion date	December 2025

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