An interventional study of Near-infrared spectrometer in Hepatic Transplantation and Steatohepatitis, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Other
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.
662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 431 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
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Liver grafts:
Surgical specimens (hepatectomy):
Exclusion Criteria:
Liver grafts:
Surgical specimens (hepatectomy):
Device: Near-infrared spectrometer
Device: Near-infrared spectrometer
Scan of the liver via near-infrared spectrometer
Sensibility of near-infrared spectroscopy
Estimate the performance of near-infrared spectroscopy for quantifying hepatic steatosis (\>5%).
Time frame: through study completion, an average of 1 year
Specificity of the near-infrared spectroscopy
Time frame: From enrollement to the end of the study at 12 months
Youden's index of the near-infrared spectroscopy
Time frame: From enrollement to the end of the study at 12 months
Likelihood index + and - of the near-infrared spectroscopy
Time frame: From enrollment to the end of the study at 12 months
Nanogram likelihood ratio of the near-infrared spectroscopy
Time frame: From enrollement to the end of the study at 12 months
ROC curve of the near-infrared spectroscopy
Time frame: From enrollement to the end of the study at 12 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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