Utilization of MAsS in Patients Undergoing LT for HCC

Terminated

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

• Registration Number: NCT05184283
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study First Submitted: 2021-12-22
• Study First Submitted QC: 2021-12-22
• Study First Posted: 2022-01-11
• Study Start: 2022-06-16
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean muscle volume	Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)	Muscle volume will be collected using body composition MR image acquisition that adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination.
Change in mean muscle fat	Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)	Muscle fat will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination

Secondary Outcome Measures

Name	Time	Method
MRI-proton density fat fraction (MRI-PDFF)	Baseline (0-12 months prior to transplant), Day 180 (post-transplant), 1 year (post-transplant)	This is to measure/assess intrahepatic fat (IHF) using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination
Number of participants that dropped out of study	1 year	This is to measure how many participants did not complete the study for any cause
Delta HOMA-IR	1 year	Delta homeostasis model assessment of insulin resistance (HOMA-IR) will be assessed using plasma glucose, insulin
Survival Rate	Day 90, Day 180, 1 year	The percentage of people that are still alive at each time point post transplant compare to 89% average survival rate
Visceral adipose tissue volume	1 year	Visceral adipose tissue volume will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination
Abdominal subcutaneous adipose tissue volume	1 year	Abdominal subcutaneous adipose tissue volume will be collected using body composition MR image acquisition adds about 6-8 minutes acquisition time to the clinically prescribed MRI examination

Trial Locations

Locations (1)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States