Hepatic TransplantationSTEATO-NIRNCT07254533
Diagnosis and Quantification of Hepatic Steatosis Using Near-infrared Spectroscopy
A study testing Near-infrared spectrometer in people with Hepatic Transplantation and Steatohepatitis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Transplantation, Steatohepatitis
- What is being tested?
- Near-infrared spectrometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2027to Jan 2028
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Timone Hospital
Marseille, 13005
Sophie Chopinet, 0491435817 ext. +33, promotion.interne@ap-hm.fr
About this study
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.
Read more
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.
- Conditions
- Hepatic Transplantation, Steatohepatitis
- Being tested
- Near-infrared spectrometer
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectrometerDevice
Scan of the liver via near-infrared spectrometer
| Study group | Role | What they receive |
|---|---|---|
| liver grafts | Experimental | Not described Receives: Device: Near-infrared spectrometer |
| Surgical specimens (hepatectomy) | Experimental | Not described Receives: Device: Near-infrared spectrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility of near-infrared spectroscopy
Estimate the performance of near-infrared spectroscopy for quantifying hepatic steatosis (>5%).
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Specificity of the near-infrared spectroscopy
Measured: From enrollement to the end of the study at 12 months
Youden's index of the near-infrared spectroscopy
Measured: From enrollement to the end of the study at 12 months
Likelihood index + and - of the near-infrared spectroscopy
Measured: From enrollment to the end of the study at 12 months
Nanogram likelihood ratio of the near-infrared spectroscopy
Measured: From enrollement to the end of the study at 12 months
ROC curve of the near-infrared spectroscopy
Measured: From enrollement to the end of the study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic TransplantationStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254533
- Sponsor's protocol ID
- RCAPHM24_0352
- Other IDs
- 2024-A02004-43
- Acronym
- STEATO-NIR
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided