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

January 5, 2024 updated by: Xiao Xu, Zhejiang University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Postoperative mortality
Time Frame: 2015.1.1-2022.12.31
2015.1.1-2022.12.31
Postoperative recurrence of liver cancer
Time Frame: 2015.1.1-2022.12.31
2015.1.1-2022.12.31

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Hospital of Qingdao University
First Affiliated Hospital of Zhejiang University
Shulan (Hangzhou) Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 17, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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