Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-14

Study Completion Date

2024-11-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Transplants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver transplants

Whole liver transplants proposed for organ harvesting from brain-dead donors and assigned by the Biomedicine Agency.

intraoperative spectrometer scan

Intervention Type OTHER

intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta

Interventions

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intraoperative spectrometer scan

intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No