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

NCT ID: NCT06209775

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

996 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplantation Body Composition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

Shulan (Hangzhou) Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role collaborator

Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xiao Xu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38489552 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CT2023-ZJU-OBS5

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

China Health Big Data
NCT03699228 RECRUITING