"LiverColor": Machine Learning in Liver Photographs

NCT ID: NCT05202886

Last Updated: 2022-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Death Liver Steatosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Liver from deceased donors
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Liver from deceased donors

Intervention Type DIAGNOSTIC_TEST

Liver donors photographed

Interventions

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Liver from deceased donors

Liver donors photographed

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Vall d'Hebron

OTHER

Sponsor Role lead

Responsible Party

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Concepción Gomez Gavara

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Concepcion Gómez-Gavara, PhD

Role: PRINCIPAL_INVESTIGATOR

Vall D´Hebron University Hospital

Locations

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Concepción Gómez-Gavara

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Concepcion Gómez-Gavara, PhD

Role: CONTACT

+34696690464

Facility Contacts

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Concepción Gómez-Gavara, PhD

Role: primary

0034696690464

Other Identifiers

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PR(AG)04/2018

Identifier Type: -

Identifier Source: org_study_id

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