Clinical trial NCT05184283: Utilization of MAsS in Patients Undergoing LT for HCC
Official title: Longitudinal Assessment of Muscle Health in Patients Undergoing Liver Transplantation (LT) for Hepatocellular Carcinoma (HCC)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: NAFLD
Hepatocellular Carcinoma
Liver Diseases
Liver Cancer
Cirrhosis, Liver
Hepatitis C
Keywords: NAFLD
Hepatocellular Carcinoma
Liver Diseases
Liver Cancer
Cirrhosis, Liver
Hepatitis C
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Amra Medical AB
First posted: 2022-01-11
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Undergoing Liver Transplantation for Hepatocellular Carcinoma at risk of nonalcoholic fatty liver disease (NAFLD), alcoholic liver disease and hepatitis C virus (HCV), among other etiologies of chronic liver injury

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in mean muscle volume
timeFrame: Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)
measure: Change in mean muscle fat
timeFrame: Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)
Secondary outcomes:
measure: Survival Rate
timeFrame: Day 90, Day 180, 1 year
measure: Number of participants that dropped out of study
timeFrame: 1 year
measure: MRI-proton density fat fraction (MRI-PDFF)
timeFrame: Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)
measure: Visceral adipose tissue volume
timeFrame: 1 year
measure: Abdominal subcutaneous adipose tissue volume
timeFrame: 1 year
measure: Delta HOMA-IR
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University Irving Medical Center/ New York Presbyterian hospital
name: Julia Wattacheril, MD
role: PRINCIPAL_INVESTIGATOR
References:
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