Utilization of MAsS in Patients Undergoing LT for HCC

Columbia University

Status: Terminated

Conditions: Cirrhosis, Liver; Hepatitis C; Hepatocellular Carcinoma; NAFLD; Liver Cancer; Liver Diseases

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05184283

AAAT7360

Details and patient eligibility

About

The aim of this study is to determine the effects of liver transplantation and standard immunosuppression on body composition in patients with compensated cirrhosis and hepatocellular carcinoma.

Full description

The combination of hepatocellular carcinoma and chronic liver disease represents a dual impact on overall metabolism. The major risk factors for chronic liver disease related-hepatocellular carcinoma (HCC) include nonalcoholic fatty liver disease (NAFLD), alcoholic liver disease and hepatitis C virus (HCV), among other etiologies of chronic liver injury.

Of particular interest is how the changing landscape of liver disease impacts the care of patients in the peritransplant period. Numerous recent studies have reported that nonalcoholic steatohepatitis (NASH)-related cirrhosis is the most rapidly growing indication for liver transplantation (LT) in the Western world. NAFLD related HCC is already a leading indication in women. The impact of NAFLD on public health and mortality is substantial: incident decompensated cirrhosis due to NAFLD is predicted to increase by 168%, from 39,230 cases annually in 2015 to 105,430 cases in 2030. The corresponding burden of NAFLD cirrhosis on liver transplantation (LT) is expected to increase by 59%. Finally, 3% per year of cirrhotic patients because of NAFLD, develop HCC and noncirrhotic NAFLD-HCC continues to be an area of investigation.

Since NAFLD is becoming one of the most frequent causes of cirrhosis, HCC, and liver transplantation worldwide, it is crucial to identify changes in the peritransplant period that are associated with adverse muscle health and unfavorable metabolic status in the context of all chronic liver diseases.

Enrollment: 11 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 75 years
• Diagnosis of cirrhosis and HCC
• Listed or in evaluation for liver transplantation

Exclusion criteria

• History of prior solid organ transplantation
• In evaluation or listed for any other solid organ transplant (other than liver transplant)
• Contraindication to MR examination
• Metastatic HCC

Trial design

11 participants in 1 patient group

Prospective Cohort

Description:

Chart review will be performed for patients who consent to inclusion in the study. Information from routine care will be reviewed and body composition assessment will be done by routine MRI with an additional 6-8 minute scan using AMRA® Profiler 4 Muscle Assessment Score (MAsS) by performing volumetric quantification of fat and water images acquired with 2-point Dixon magnetic resonance imaging (MRI).