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NCT05202886 Clinical Trial

"LiverColor": Machine Learning in Liver Photographs

Brain Death Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05202886
Other study ID # PR(AG)04/2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 30, 2018
Est. completion date December 31, 2023

Study information
Verified date January 2022
Source Hospital Vall d'Hebron
Contact Concepcion Gómez-Gavara, PhD
Phone +34696690464
Email imgoga@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 246
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Liver from deceased donors
Liver donors photographed

Locations
Country Name City State
Spain Concepción Gómez-Gavara Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 To build an image dataset to evaluate postransplant liver function. PDF will be evaluated according to Olthoff criteria 1 week
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