"LiverColor": Machine Learning in Liver Photographs

January 20, 2022 updated by: Concepción Gomez Gavara, Hospital Vall d'Hebron

"LiverColor": AN ALGORITHM QUANTIFICATION OF LIVER GRAFT STEATOSIS USING MACHINE LEARNING AND COLOR IMAGE PROCESSING

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Surgeons (junior and senior operators) from the HBP & Transplantation Unit took the pictures. They were taken after the laparotomy and before any type of surgical procedure. For each deceased donor case, a total of 5 pictures were taken: one for the left lobe and another for the right one before undergoing a surgical biopsy, two more (one for the left and one for the right lobe) after the histological analysis, near to the site of the surgical biopsy, and finally, one picture after liver perfusion.

Study Type

Interventional

Enrollment (Anticipated)

246

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

  • Name: Concepcion Gómez-Gavara, PhD
  • Phone Number: +34696690464
  • Email: imgoga@hotmail.com

Study Locations

  • Spain
      • Barcelona, Spain
        • Recruiting
        • Concepción Gómez-Gavara
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Livers from donor donor brain death with informed consent before inclusion in the study was obtained from all participants or families.

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liver from deceased donors
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
Liver donors photographed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 4 weeks
Accuracy
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To build an image dataset to evaluate postransplant liver function.
Time Frame: 1 week
PDF will be evaluated according to Olthoff criteria
1 week

Collaborators and Investigators

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

Sponsor

Hospital Vall d'Hebron

Investigators

  • Principal Investigator: Concepcion Gómez-Gavara, PhD, Vall d´Hebron University 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)

June 30, 2018

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

January 20, 2022

First Posted (Actual)

January 24, 2022

Study Record Updates

Last Update Posted (Actual)

January 24, 2022

Last Update Submitted That Met QC Criteria

January 20, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PR(AG)04/2018

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

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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