Brain DeathNCT05202886
"LiverColor": Machine Learning in Liver Photographs
A study testing Liver from deceased donors in people with Brain Death and Liver Steatosis, run by Hospital Vall d'Hebron at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Death, Liver Steatosis
- What is being tested?
- Liver from deceased donors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jun 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Livers from donor donor brain death with informed consent before inclusion in the study was obtained from all participants or families.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Concepción Gómez-Gavara
Barcelona
Concepción Gómez-Gavara, PhD, 0034696690464, imgoga@hotmail.com
About this study
Official title: "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.
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.
- Conditions
- Brain Death, Liver Steatosis
- Being tested
- Liver from deceased donors
- Keywords
- machine learning, liver donor (DBD), liver steatosis, liver pictures, liver pool
- Medical subject headings
- Brain Death, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver from deceased donorsDiagnostic test
Liver donors photographed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Liver from deceased donors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (1)
To build an image dataset to evaluate postransplant liver function.
PDF will be evaluated according to Olthoff criteria
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start30 Jun 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Liver from deceased donors
- Masking
- None (open label)
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Vall d'Hebron
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Concepción Gomez Gavara, Hospital Vall d'Hebron
- Investigators
- Concepcion Gómez-Gavara, PhD, Principal investigator, Vall D´Hebron University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202886
- Sponsor's protocol ID
- PR(AG)04/2018
- Status last verified
- Jan 2022
- First submitted
- 8 Jun 2021
- Last updated
- 24 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "LiverColor": AN ALGORITHM QUANTIFICATION OF LIVER GRAFT STEATOSIS USING MACHINE LEARNING AND COLOR IMAGE PROCESSING
- ClinicalTrials.gov ID
- NCT05202886
- Acronym / sponsor ID
- PR(AG)04/2018
- Conditions
- Brain Death, Liver Steatosis
- Keywords
- machine learning, liver donor (DBD), liver steatosis, liver pictures, liver pool
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Hospital Vall d'HebronUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Liver from deceased donors
| Arm | Type | Receives |
|---|---|---|
| Liver from deceased donors | Experimental | Diagnostic Test: Liver from deceased donorsThis study included all consecutive subjects with chronic liver disease who underwent LT for the first time with a deceased donor liver |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Livers from donor donor brain death with informed consent before inclusion in the study was obtained from all participants or families.
Key exclusion criteria (7 listed)
- Age < 18 years old
- Donor after cardiac death
- Split
- Cholestasis due to a biliary obstruction
- Total bilirubin levels above 2,5 mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver from deceased donorsLiver donors photographed | Diagnostic test | Liver from deceased donors |
Primary outcome
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
1 secondary outcome
To build an image dataset to evaluate postransplant liver function.
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Concepcion Gómez-Gavara, PhD principal investigator
Vall D´Hebron University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver from deceased donors in people with Brain Death and Liver Steatosis, run by Hospital Vall d'Hebron at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Concepcion Gómez-Gavara, PhD (+34696690464, imgoga@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2022.