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

Recruiting
18 years or above
All
Phase N/A
240 participants needed

Brief description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Liver Transplants
  • Age: 18 years or above
  • Gender: All

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

Updated on 24 Jun 2024. Study ID: APHP210949

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