Impact of Perioperative Body Composition Abnormalities on Patient Outcomes After Liver Transplantation

Accumulating evidence suggests the prognostic significance of body composition in chronic diseases and neoplastic diseases. CT imaging-based body composition abnormalities are significantly associated with post-LT adverse outcomes including decreased quality of life (QOL), impaired graft regeneration and mortality. However, the perioperative changes in body composition and their potential clinical implications remain unexplored. The objective of this study is to systematically explore and clarify the correlation between body composition and the prognosis of liver transplant patients through dynamic peri-transplant mornitoring.

Study Overview

• Status: Completed
• Conditions: Liver Transplantation; Body Composition

• Study Type: Observational
• Enrollment (Actual): 996

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 3 transplant centers in China

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Pediatric transplants
• Re-transplants
• Multi-organ transplants
• Liver cancer patients with macrovascular invasion or distant metastasis
• Patients who died within 30 days after transplantation

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Split liver transplantation group; Between January 1, 2015 and December 31, 2022, all recipients who underwent split liver transplantation at the First Affiliated Hospital of the Zhejiang University School of Medicine, Shulan (Hangzhou) Hospital and the Affiliated Hospital of Qingdao University were considered for inclusion. After exluding pediatric cases, multiorgan transplantations, liver cancer patients with macrovascular invasion or distant metastasis and recipients without computed tomography (CT) scan within three months before split liver transplantation, 240 patients were included. The procedures of organ donation and transplantation were strictly implemented under the regulation of the China Organ Donation Committee (CODC), Organ Transplant Committee (OTC) and the Declaration of Helsinki (as revised in 2013). All donor livers came from donation after citizens' death and there was no procurement from prisoners.
Whole liver transplantation group; 2991 patients received deceased donor liver transplantation (DDLT) for liver cancers in the First Affiliated Hospital of Zhejiang University School of Medicine (Hangzhou, China) between January 2015 and January 2021, Shulan (Hangzhou) Hospital (Hangzhou, China) between July 2017 and January 2021, and the Affiliated Hospital of Qingdao University between January 2015 and January 2022. The subject selection process is shown in Figure 1. After excluding transplants for benign disease (N=1667), pediatric transplants (N=141), re-transplants (N=219), multi-organ transplants (N=23), transplants for neoplasms other than HCC (N=62), patients with macrovascular invasion (N=159), patients who died within 30 days after transplantation (N=55), patients with incomplete clinical data (N=45), and patients without pre-LT CT scans (N=208), 756 patients were studied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative mortality	2015.1.1-2022.12.31
Postoperative recurrence of liver cancer	2015.1.1-2022.12.31

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 5, 2024
• First Posted (Estimated): January 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: CT2023-ZJU-OBS5

Drug and device information, study documents

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