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NCT06188273 Clinical Trial

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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06188273
Other study ID # CT2023-ZJU-OBS3
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2024
Est. completion date January 1, 2029

Study information
Verified date December 2023
Source Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 800
Est. completion date January 1, 2029
Est. primary completion date January 1, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (6)
Lead Sponsor Collaborator
Zhejiang University First Affiliated Hospital of Zhejiang University, Huashan Hospital, Shulan (Hangzhou) Hospital, The Affiliated Hospital of Qingdao University, West China Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative mortality 2024.1.1-2027.1.1
Primary Postoperative recurrence of liver cancer Specifically for the included patients who undergo liver transplantation for liver cancer 2024.1.1-2027.1.1
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