NCT06626724

Brief Summary

Background: This study aimed to develop a predictive model for delayed graft function (DGF) in liver transplant patients with hepatocellular carcinoma (HCC) based on preoperative biochemical indicators, using both logistic regression and XGBoost machine learning algorithms. Methods: A retrospective cohort study was conducted, including 131 liver transplant patients from January 2020 to April 2022. Preoperative biochemical markers and hematological parameters were analyzed. Logistic regression and XGBoost models were constructed to predict DGF, and their performance was evaluated using the area under the ROC curve (AUC). Shapley Additive Explanations (SHAP) analysis was employed to interpret the feature contributions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

4.3 years

First QC Date

October 1, 2024

Last Update Submit

October 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • TBIL/AST/ALT/INR

    Results of biochemical examination on the 7th day after liver transplantation in patients with hepatocellular carcinoma.

Interventions

Liver transplantation for patients with hepatocellular carcinoma.

Eligibility Criteria

Age18 Days - 75 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients receiving a liver transplant between January 2020 and April 2024.

You may qualify if:

  • Patients with liver cancer aged between 18 and 75 years.
  • Patients who have received liver transplantation.
  • Complete preoperative and postoperative medical imaging data, clinical records and pathological test reports are available.

You may not qualify if:

  • Primary non-hepatocellular carcinoma
  • Recipients were younger than 18 years and older than 75 years
  • Serious complications associated with liver transplantation, such as acute transplant rejection or transplant liver failure, occur within 7 days after surgery.
  • Re-surgery within 7 days after surgery due to liver transplant-related complications or other surgical procedures, such as transplant site infection or other major surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsDigestive System Surgical ProceduresSurgical Procedures, OperativeOrgan TransplantationTransplantation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 4, 2024

Study Start

January 1, 2020

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

October 4, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

The data are not publicly available, as participants in this study need their data for further analysis.

Locations