ClinicalTrials.gg
Status unknownNCT05202886Updated Jan 24, 2022

"LiverColor": Machine Learning in Liver Photographs

An interventional study of Liver from deceased donors in Brain Death and Liver Steatosis, sponsored by Hospital Vall d'Hebron. Status unknown at 1 site in Spain. Per ClinicalTrials.gov, last updated 2022-01-24.

Sponsored by Hospital Vall d'Hebron · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 11 months after the study started (first participant enrolled Jun 2018, registered Jun 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
246
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Brain Death
  • Liver Steatosis

Keywords

  • machine learning
  • liver donor (DBD)
  • liver steatosis
  • liver pictures
  • liver pool
03

In context

Brain Death

74 studies on the registry are indexed under Brain Death; 10 are open to participants now.

This study's planned enrollment of 246 is above the median of 154 across 39 interventional studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

Hospital Vall d'Hebron is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Age \< 18 years old
  • Donor after cardiac death
  • Split
  • Cholestasis due to a biliary obstruction
  • Total levels above 2,5 mg/dL
  • Glutamic oxaloacetic transaminase ()/ serum glutamatepyruvate transaminase (SGPT) levels and gamma-glutamyl transaminase (GGT) levels above 400 U/L
  • Cirrhotic livers
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
246 participants (estimated)

Study arms

  • 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

Interventions

  • Diagnostic testLiver from deceased donors

    Liver donors photographed

06

What researchers measure

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

    Time frame: 4 weeks

Secondary outcomes

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

    PDF will be evaluated according to Olthoff criteria

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • Concepción Gómez-Gavara
    Barcelona, Spain
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05202886
Lead sponsor
Hospital Vall d'Hebron
Responsible party
Concepción Gomez Gavara (PhD, Hospital Vall d'Hebron) — Principal investigator
First posted
Jan 24, 2022
Start date
Jun 30, 2018
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Jan 24, 2022

Study contacts

Concepcion Gómez-Gavara, PhD
Contact
imgoga@hotmail.com
+34696690464
Concepcion Gómez-Gavara, PhD
principal investigator · Vall D´Hebron University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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