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

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Liver Transplants

Treatments: Other: intraoperative spectrometer scan

Study type: Observational

Funder types: Other

Identifiers

NCT05106322

APHP210949

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

240 participants in 1 patient group

Liver transplants

Description:

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

Treatment:

Other: intraoperative spectrometer scan