NCT05779098

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,071

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

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

First Submitted

Initial submission to the registry

March 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

March 9, 2023

Last Update Submit

May 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative liver failure

    1-5 days after surgery

Study Arms (1)

Extensive hepatectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Extensive Hepatology in our hospital

You may qualify if:

  • Extensive hepatectomy in our hospital(≥ three Hepatic segment)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, 200092, China

Location

Related Publications (1)

  • Shen H, Yuan T, Si A, Shen Y, Liu J, Jin L, Xie Z, Zhang H, Wei W, Dai Y, Jiang T, He C, Zhang S, Hu Y, Huang S, Yang Z, Chen Y, Zhang X, Shen F, Qi X, Li J. Liver regeneration-associated machine learning architecture integrating time-phased predictions for post-hepatectomy liver failure. EClinicalMedicine. 2025 Nov 28;90:103661. doi: 10.1016/j.eclinm.2025.103661. eCollection 2025 Dec.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dean of Clinical Research Institute of Eastern Hepatobiliary Surgery Hospital

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 22, 2023

Study Start

April 1, 2023

Primary Completion

April 1, 2025

Study Completion

April 1, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations