NCT05202886

Brief Summary

The main goal of this project is to create a machine learning model in order to quantify liver steatosis in liver donor faster, more objective and reliable than histological analysis and surgeons point-of-view.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 30, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

January 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 24, 2022

Status Verified

January 1, 2022

Enrollment Period

5.5 years

First QC Date

June 8, 2021

Last Update Submit

January 20, 2022

Conditions

Keywords

machine learningliver donor (DBD)liver steatosisliver picturesliver pool

Outcome Measures

Primary Outcomes (1)

  • The main goal of this project is to create a machine learning model in order to quantify liver steatosis in liver donor faster, more objective and reliable than histological analysis and surgeons point-of-view.

    Accuracy

    4 weeks

Secondary Outcomes (1)

  • To build an image dataset to evaluate postransplant liver function.

    1 week

Study Arms (1)

Liver from deceased donors

EXPERIMENTAL

This study included all consecutive subjects with chronic liver disease who underwent LT for the first time with a deceased donor liver

Diagnostic Test: Liver from deceased donors

Interventions

Liver donors photographed

Liver from deceased donors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Age \< 18 years old
  • Donor after cardiac death
  • Split
  • Cholestasis due to a biliary obstruction
  • Total bilirubin levels above 2,5 mg/dL
  • Glutamic oxaloacetic transaminase (SGOT)/ serum glutamatepyruvate transaminase (SGPT) levels and gamma-glutamyl transaminase (GGT) levels above 400 U/L
  • Cirrhotic livers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Concepción Gómez-Gavara

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Brain DeathFatty Liver

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Study Officials

  • Concepcion Gómez-Gavara, PhD

    Vall D´Hebron University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Concepcion Gómez-Gavara, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Liver from deceased donors
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 8, 2021

First Posted

January 24, 2022

Study Start

June 30, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

January 24, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations