iGRAISSE: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05106322

Collaborator

(none)

240

Enrollment

Location

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplants	Other: intraoperative spectrometer scan

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Liver transplants Whole liver transplants proposed for organ harvesting from brain-dead donors and assigned by the Biomedicine Agency.	Other: intraoperative spectrometer scan intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta

Arm

Intervention/Treatment

Liver transplants

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

Other: intraoperative spectrometer scan

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

Outcome Measures

Primary Outcome Measures

Evaluate the concordance between the macrosteatosis quantified by the pocket spectrometer and the macrosteatosis content evaluated by the standard pathological analysis [J0 = intraoperative]
Agreement (intra-class correlation coefficient) between the% of macrosteatosis estimated by the pocket spectrometer and that quantified by the pathologist on biopsy (final results only)

Secondary Outcome Measures

Evaluation of the spectrometer performance for diagnosis to detect macrosteatosis> 30% and> 60% taking the pathology as a reference standard [J0 = intraoperative]
Area under the ROC curve (AUC), sensitivity, specificity, likelihood ratio and predictive values of the spectrometer to detect macrosteatosis> 30% and> 60%
Assessment of the technical feasibility of using the spectrometer in daily practice, analysis of the causes and incidence of failures (technical or organizational) [J0 = intraoperative]
Number of time where the measurement by the pocket spectrometer was successful, ie where it was possible to perform the scans and obtain an estimate of the macrosteatosis, and description of the causes for failure.
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 [J0 = intraoperative]
Agreement (intra-class correlation coefficient) between the% of macrosteatosis estimated by the pathologist extemporaneously when performed and te one quantified by the pathologist on biopsy (final results only).
Assessment of the concordance between the macrosteatosis visually assessed by the harvesting surgeon and the definitive pathological data [J0 = intraoperative]
Agreement (kappa coefficient) between the% of macrosteatosis macroscopically estimated by the pathologist (in 3 categories: 0-30%, 31-60%,> 60%) and that quantified by the pathologist on biopsy (final results only )
Evaluation of the potential impact of spectrometer results on the surgeon's decision to accept the graft using simulated results [J0 = intraoperative]
Percentage of acquisitions where the operator would have modified his decision (accept / reject the graft) if the spectrometer estimate had been communicated (scenarios simulated in the questionnaires)
Modification and improvement of the current algorithm based on the spectra of the entire cohort in order to assess the gain in "spectrometer - anatomopathology" [J0 = intraoperative]
Agreement (intra-class correlation coefficient) between the percentage of macrosteatosis estimated by the spectrometer using the second version of the algorithm and the macrosteatosis quantified by pathology
Attempt to create a microsteatosis prediction algorithm (version 3) using data from the global cohort [J0 = intraoperative]
Agreement (intra-class correlation coefficient) between the percentage of microsteatosis estimated by the spectrometer and the microsteatosis quantified by the pathology

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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