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Trial Radar IA
Lo studio clinico NCT07254533 (STEATO-NIR) per Hepatic Transplantation, Steatoepatite è non ancora in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui.
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Diagnosis and Quantification of Hepatic Steatosis Using Near-infrared Spectroscopy (STEATO-NIR)

Non ancora in arruolamento
I dettagli dello studio clinico sono disponibili principalmente in inglese. Tuttavia, Trial Radar IA può essere d'aiuto! Basta cliccare su 'Spiega lo studio' per visualizzare e discutere le informazioni sullo studio nella lingua selezionata.
La sperimentazione clinica NCT07254533 (STEATO-NIR) è uno studio interventistico per Hepatic Transplantation, Steatoepatite, attualmente non ancora in arruolamento. L'arruolamento dovrebbe iniziare il 1 gennaio 2026, con l'obiettivo di raggiungere 90 partecipanti. Sotto la guida di Assistance Publique Hopitaux De Marseille, dovrebbe concludersi entro il 1 gennaio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 28 novembre 2025.
Sommario breve
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.

Titolo ufficiale

Diagnosis and Quantification of Hepatic Steatosis Using Near-infrared Spectroscopy

Condizioni
Hepatic TransplantationSteatoepatite
Altri ID dello studio
  • STEATO-NIR
  • RCAPHM24_0352
  • 2024-A02004-43 (Altro identificativo) (IDRCB)
Numero NCT
Data di inizio (effettiva)
2026-01
Ultimo aggiornamento pubblicato
2025-11-28
Data di completamento (stimata)
2027-01
Arruolamento (previsto)
90
Tipo di studio
Interventistico
FASE
N.D.
Stato
Non ancora in arruolamento
Scopo principale
Altro
Allocazione
Non randomizzato
Modello di intervento
In parallelo
Mascheramento
Nessuno (studio in aperto)
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Sperimentaleliver grafts
Near-infrared Spectrometer
Scan of the liver via near-infrared spectrometer
SperimentaleSurgical specimens (hepatectomy)
Near-infrared Spectrometer
Scan of the liver via near-infrared spectrometer
Esito primario
Misure di esitoDescrizione della misuraArco temporale
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
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
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
Criteri di eleggibilità

Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti

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

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
Assistance Publique Hopitaux De Marseille logoAssistance Publique Hopitaux De Marseille
Contatti principali dello studio
Contatto: Sophie Chopinet, Dr, 0491435817, [email protected]
1 Centri dello studio in 1 paesi
Timone Hospital, Marseille, 13005, France
Sophie Chopinet, Contatto, 0491435817, [email protected]