Clinical trial NCT05106322: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
Official title: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Transplants
Keywords: macrosteatosis
spectrometry
liver transplantation
biopsy
primary non-function
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Whole liver transplants proposed for organ harvesting from brain-dead donors assigned by the Biomedicine Agency

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate the concordance between the macrosteatosis quantified by the pocket spectrometer and the macrosteatosis content evaluated by the standard pathological analysis
timeFrame: J0 = intraoperative
Secondary outcomes:
measure: Evaluation of the spectrometer performance for diagnosis to detect macrosteatosis> 30% and> 60% taking the pathology as a reference standard
timeFrame: J0 = intraoperative
measure: Assessment of the technical feasibility of using the spectrometer in daily practice, analysis of the causes and incidence of failures (technical or organizational)
timeFrame: J0 = intraoperative
measure: Estimation of the concordance between the macrosteatosis values provided by the frozen section analysis, if performed, and the definitive pathology and comparison with the concordance of the pocket spectrometer estimated for the primary objective
timeFrame: J0 = intraoperative
measure: Assessment of the concordance between the macrosteatosis visually assessed by the harvesting surgeon and the definitive pathological data
timeFrame: J0 = intraoperative
measure: Evaluation of the potential impact of spectrometer results on the surgeon's decision to accept the graft using simulated results
timeFrame: J0 = intraoperative
measure: Modification and improvement of the current algorithm based on the spectra of the entire cohort in order to assess the gain in "spectrometer - anatomopathology"
timeFrame: J0 = intraoperative
measure: Attempt to create a microsteatosis prediction algorithm (version 3) using data from the global cohort
timeFrame: J0 = intraoperative
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hôpital Beaujon
state: Ile De France
city: Paris
country: France
facility: Hôpital Pitié-Salpetriere
state: Ile De France
city: Villejuif
country: France
facility: Centre Hépato Biliaire de l'hopital Paul Brousse
Study officials:
affiliation: APHP
name: Nicolas GOLSE
role: PRINCIPAL_INVESTIGATOR
References: