A Machine Learning Architecture to Predict Post-Hepatectomy Liver Failure Using Liver Regeneration Biomarkers and Time-Phased Data (PHLF predictio)

May 18, 2025 updated by: Shen Feng
Post-hepatectomy liver failure (PHLF) is the leading cause of morbidity and mortality following major hepatectomy. Existing prediction models fail to capture the dynamic liver regeneration and perioperative changes, limiting their predictive accuracy. We aimed to develop a machine learning (ML) modelling system (PILOT architecture) integrating liver regeneration biomarkers with time-phased perioperative clinical data to accurately predict PHLF risk.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1071

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200092
        • Department of Hepatobiliary and Pancreatic Surgery, Tenth People's Hospital of Tongji University, School of Medicine, Tongji University, Shanghai, China

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with Extensive Hepatology in our hospital

Description

Inclusion Criteria:

Extensive hepatectomy in our hospital（≥ three Hepatic segment）

Exclusion Criteria:

Serious basic diseases Intolerable surgery Refuse to perform ICG test before operation

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
Intervention / Treatment
Extensive hepatectomy
Procedure: Extensive hepatectomy
Extensive hepatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative liver failure
Time Frame: 1-5 days after surgery
1-5 days after surgery

Collaborators and Investigators

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

Sponsor

Shen Feng

Collaborators

Shanghai 10th People's Hospital
Jinling Hospital, China

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)

April 1, 2023

Primary Completion (Actual)

April 1, 2025

Study Completion (Actual)

April 1, 2025

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 21, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 18, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1312871874

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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