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

NCT06188273 | Not Yet Recruiting DMC

• 1 other identifier: CT2023-ZJU-OBS3
• Study Type: observational
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Transplantation; Muscle Loss; Muscle Quality

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Liver transplant patients from multiple transplant centers in China

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhejiang University: lead
• First Affiliated Hospital of Zhejiang University: collaborator
• Shulan (Hangzhou) Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• West China Hospital: collaborator
• Huashan Hospital: collaborator

MeSH Terms

Conditions

Muscular Atrophy

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 3, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 3, 2024

Record last verified: 2023-12