Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry (iGRAISSE)

  • STATUS
    Recruiting
  • participants needed
    240
  • sponsor
    Assistance Publique - Hôpitaux de Paris
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Updated on 5 May 2025
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Summary

The goal is to have a small spectrometer (pocket size) , reliable and rapid tool that can be used during liver harvesting, which enables macrosteatosis to be evaluated reproducibly and selectively, at any time.

This tool must be minimally invasive, inexpensive and without significantly impacting the general organization of multi-organ harvesting.

In the operating room, the surgeon will perform an intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta. The surgeon will not be informed of the results of the spectrometer, and will carry out (or not) the biopsy. The spectrometers' results will be compared with definitive histological findings.

Details
Condition Liver Transplants
Age 18years or above
Clinical Study IdentifierNCT05106322
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on5 May 2025

Eligibility

 Yes No Not Sure

Inclusion Criteria

Brain-dead donor
Age ≥18 years old
No restriction on the part of the donor or his family regarding the use of the data for research purposes
No fibrous appearance of the graft (visual assessment), corresponding to a Metavir score ≥ F2

Exclusion Criteria

Living donor
Donor within the Maastricht III criteria (cardiac arrest)
Pre-existing hepatic injury / trauma preventing the intraoperative use of the pocket spectrometer
History of supra-mesocolic surgery or peritonitis leading to perihepatic adhesions (preventing the use of pocket spectrometer)
History of chemotherapy -- Biological cholestasis
GGT> 400 IU / L
or total bilirubin ≥ 60micromol / L
or conjugated bilirubin ≥ 30micromol / L
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