Quantitative Liver Function Tests Using Cholates
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 10/20/2017 |
| Start Date: | July 2011 |
| End Date: | December 2020 |
| Contact: | Kaylee Lirely, RN/BSN |
| Email: | Kaylee.Lirely@BSWHealth.org |
| Phone: | 214-820-1771 |
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.
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.
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
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
Inclusion Criteria:
- End-stage liver disease patient or Living Liver Donor or Congenital Heart Disease
patients
- Age: 18 yr to 80 yr
- Patients or Legal Authorized Representative (LAR) must provide written consent and be
willing and able to adhere to study requirements
- Stage 3-4 fibrosis by METAVIR score or clinical evidence of advanced fibrosis
(End-stage liver disease patients only)
Exclusion Criteria:
- Hepatic encephalopathy Grade 3 or 4
- Pregnancy or intent to become pregnant
- Subjects with inability to provide consent for one's self
- Subjects with a life expectancy < 1 year
- Subjects who have participated in an investigational drug study within the past 30
days
We found this trial at
1
site
3500 Gaston Avenue
Dallas, Texas 75246
Dallas, Texas 75246
1.800.422.9567
Phone: 214-820-1771
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