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
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Liver Transplantation
• Muscle Loss
• Muscle Quality

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