"LiverColor": Machine Learning in Liver Photographs | NCT05202886

Studies
"LiverColor": Machine Learning in Liver Photographs

NCT05202886

Sponsor

Hospital Vall d'Hebron

Status

Unknown status

Last Update Posted

Jan 24, 2022Actual

Enrollment

246Estimated

Phase

Not Applicable

Conditions

Brain Death
Liver Steatosis

Interventions

Liver from deceased donors

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2018Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 8, 2021

First Submission Date that Met QC Criteria

Jan 20, 2022

First Posted Date

Jan 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2022

Last Update Posted Date

Jan 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

246Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Diagnostic Test: Liver from deceased donors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Liver from deceased donors	Diagnostic Test	Liver donors photographed	Liver from deceased donors

Outcomes Module

Primary Outcomes

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.	Accuracy	4 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Concepcion Gómez-Gavara, PhD	Contact	+34696690464		imgoga@hotmail.com

Overall Officials

Name	Affiliation	Role
Concepcion Gómez-Gavara, PhD	Vall D´Hebron University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Concepción Gómez-Gavara	Recruiting	Barcelona			Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001926	Brain Death
D005234	Fatty Liver

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D003128	Coma

Browse Leaves

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