Diagnosis and Quantification of Hepatic Steatosis Using Near-infrared Spectroscopy (STEATO-NIR)

In liver transplantation, the main problem is the shortage of grafts due to the small pool of donors. In order to increase the number of donors, grafts are increasingly being taken from older donors, known as 'expanded criteria' donors, who have liver steatosis lesions. Currently, expanded criteria donors account for 75% of liver transplants, whereas in 2009 they accounted for less than 30% of liver transplants.

Steatosis and its progression Non-alcoholic steatohepatitis (NASH) is an emerging disease in industrialised countries due to obesity, and corresponds to the accumulation of intracytoplasmic triglycerides.

Steatosis is diagnosed when this fat content represents more than 5% of the total liver mass. There are two types of steatosis: microvesicular steatosis and macrovacuolar steatosis, defined by the presence of lipid droplets larger than the nucleus with a nucleus displaced to the periphery. Macrovacuolar steatosis is responsible for impaired liver function if it is present in ≥30% of hepatocytes. It is a factor in poor prognosis for liver transplants, with reduced graft and recipient survival and an increase in early graft dysfunction after liver transplantation. The quantification of hepatic steatosis is based on the pathological analysis of a liver biopsy, which is currently the gold standard.

This technique has disadvantages: it is an invasive method, requiring an experienced pathologist, and presents inter-individual variability in the assessment and quantification of steatosis.

It is therefore essential to develop new non-invasive diagnostic tools that can identify the presence of steatosis > 5% and ≥ 30%. Several non-invasive techniques for diagnosing steatosis have been studied: Fibroscan, CT scan, MRI, but none of those studied previously allow for the accurate quantification of hepatic steatosis, particularly macrovacuolar steatosis, with instant results.

Study Overview

• Status: Not yet recruiting
• Conditions: Steatohepatitis; Hepatic Transplantation
• Intervention / Treatment: Device: Near-infrared spectrometer

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophie Chopinet, Dr; Phone Number: +33 0491435817; Email: promotion.interne@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13005
    • Timone Hospital
    • Contact: Sophie Chopinet; Phone Number: +33 0491435817; Email: promotion.interne@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Liver grafts:

• Men or women aged 18 and over
• All donors accepted by the MA4FC procurement team, including brain-dead donors and Maastricht 3 donors, even if placed on a perfusion machine
• Donors whose families have received information about the study and have not expressed any opposition

Surgical specimens (hepatectomy):

• Men or women aged 18 years and older
• Subjects who have undergone surgery for any indication of hepatectomy
• Affiliated with social security,
• Having received information about the study and not having expressed opposition

Exclusion Criteria:

Liver grafts:

• Donors whose liver will be subject to a SPLIT procedure
• Donors for whom there is a medical-legal obstacle
• Donors whose family or loved ones oppose scientific sampling: The hospital coordination team will consult the national refusal register and question loved ones to determine whether the deceased would have opposed sampling. If the donor and/or family oppose scientific sampling, then sampling will not be performed.

Surgical specimens (hepatectomy):

• Subjects covered by Articles L1121-5 to 1121-8 of the Public Health Code (minors, adults under guardianship or curatorship, patients deprived of their liberty, pregnant or breastfeeding women),
• Subjects who do not understand the French language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: liver grafts	Device: Near-infrared spectrometer; Scan of the liver via near-infrared spectrometer
Experimental: Surgical specimens (hepatectomy)	Device: Near-infrared spectrometer; Scan of the liver via near-infrared spectrometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensibility of near-infrared spectroscopy	Estimate the performance of near-infrared spectroscopy for quantifying hepatic steatosis (>5%).	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Specificity of the near-infrared spectroscopy	From enrollement to the end of the study at 12 months
Youden's index of the near-infrared spectroscopy	From enrollement to the end of the study at 12 months
Likelihood index + and - of the near-infrared spectroscopy	From enrollment to the end of the study at 12 months
Nanogram likelihood ratio of the near-infrared spectroscopy	From enrollement to the end of the study at 12 months
ROC curve of the near-infrared spectroscopy	From enrollement to the end of the study at 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): November 28, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: RCAPHM24_0352; 2024-A02004-43 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No