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Diagnosis and Quantification of Hepatic Steatosis Using Near-infrared Spectroscopy

Study acronym: STEATO-NIR
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jan 2027 → Jan 2028
See other at-risk trials from Assistance Publique Hopitaux De Marseille

Record History

  1. Notable Primary and study completion pushed from Jan 2027 to Jan 2028 Start date: Jan 2026 to Jan 2027 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 1 of 5 entries Show 3 more changesShow less
    • Start date: Jan 2026 to Jan 2027
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 5 entries
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07254533
Lead Sponsor Assistance Publique Hopitaux De Marseille
Conditions Hepatic Transplantation, Steatohepatitis
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov