Impact of Skeletal Muscle Quality and Loss on the Outcome of Liver Transplantation

CT imaging-based skeletal muscle assessment has been found to predict the outcomes of many diseases. Previous evidence revealed that pre-transplant muscle quality and post-transplant muscle loss were associated with transplant outcomes. However, there is no prospective study supporting the aforementioned conclusions. This study aims to prospectively include liver transplant patients from multiple transplant centers, collecting their pre-transplant CT images as well as post-transplant CT images at specific time points. The objective is to further explore and clarify the correlation between skeletal muscle assessment and the prognosis of liver transplant patients. The goal is to provide guidance for peri-transplant health monitoring and disease intervention for liver transplant patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Transplantation; Muscle Loss; Muscle Quality

• Study Type: Observational
• Enrollment (Estimated): 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Liver transplant patients from multiple transplant centers in China

Description

Inclusion Criteria:

• Adult patients undergoing deceased donor liver transplantation (DDLT) for the first time

Exclusion Criteria:

• Pediatric transplants
• Presence of portal vein tumor thrombus according to imageing before transplantation
• Presence of macrovascular invasion according to imageing before transplantation
• Re-transplants
• Multi-organ transplants
• Patients who died within 30 days after transplantation
• Patients diagnosed with skeletal muscle diseases (e.g. muscle atrophy)
• Patients with serious medical conditions such as heart failure, persistent infection, and renal insufficiency.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Myosteatotic Group; The group of patients was diagnosed with myosteatosis through CT imaging assessment before transplantation.
Non-myosteatotic Group; The group of patients was diagnosed without myosteatosis through CT imaging assessment before transplantation.
The Group with Severe Muscle Loss; The group of patients, through the comparison of CT images before and after transplantation, was diagnosed with significant muscle loss.
The Group without Severe Muscle Loss; The group of patients, through the comparison of CT images before and after transplantation, was diagnosed without significant muscle loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mortality		2024.1.1-2027.1.1
Postoperative recurrence of liver cancer	Specifically for the included patients who undergo liver transplantation for liver cancer	2024.1.1-2027.1.1

Collaborators and Investigators

• Sponsor: Zhejiang University
• Collaborators: Huashan Hospital; West China Hospital; The Affiliated Hospital of Qingdao University; First Affiliated Hospital of Zhejiang University; Shulan (Hangzhou) Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: December 17, 2023
• First Submitted That Met QC Criteria: December 17, 2023
• First Posted (Estimated): January 3, 2024

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CT2023-ZJU-OBS3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No