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

NCT06209775 | Completed DMC

• 1 other identifier: CT2023-ZJU-OBS5
• Study Type: observational
• Target: 996
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Transplantation; Body Composition

Outcome Measures

Primary Outcomes (2)

• Postoperative mortality

  2015.1.1-2022.12.31

• Postoperative recurrence of liver cancer

  2015.1.1-2022.12.31

Study Arms (2)

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.

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 3 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
• Re-transplants
• Multi-organ transplants
• Liver cancer patients with macrovascular invasion or distant metastasis
• Patients who died within 30 days after transplantation

Sponsors & Collaborators

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

Related Publications (1)

• Chen H, Hu Z, Xu Q, He C, Yang X, Shen W, Lin Z, Li H, Zhuang L, Cai J, Lerut J, Zheng S, Lu D, Xu X. The adverse impact of perioperative body composition abnormalities on outcomes after split liver transplantation: a multicenter retrospective cohort study. Int J Surg. 2024 Jun 1;110(6):3543-3553. doi: 10.1097/JS9.0000000000001303.

  PMID: 38489552 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 17, 2024
• Study Start: January 1, 2015
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: January 17, 2024

Record last verified: 2024-01