Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Study Overview
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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.

Official Title
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Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Conditions
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Liver Transplants

Intervention / Treatment
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* Other: intraoperative spectrometer scan


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the concordance between the macrosteatosis quantified by the pocket spectrometer and the macrosteatosis content evaluated by the standard pathological analysis | 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) | J0 = intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the spectrometer performance for diagnosis to detect macrosteatosis> 30% and> 60% taking the pathology as a reference standard | Area under the ROC curve (AUC), sensitivity, specificity, likelihood ratio and predictive values of the spectrometer to detect macrosteatosis> 30% and> 60% | J0 = intraoperative | 
| Assessment of the technical feasibility of using the spectrometer in daily practice, analysis of the causes and incidence of failures (technical or organizational) | 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. | J0 = intraoperative | 
| 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 | 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). | J0 = intraoperative | 
| Assessment of the concordance between the macrosteatosis visually assessed by the harvesting surgeon and the definitive pathological data | 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 ) | J0 = intraoperative | 
| Evaluation of the potential impact of spectrometer results on the surgeon's decision to accept the graft using simulated results | 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) | J0 = intraoperative | 
| Modification and improvement of the current algorithm based on the spectra of the entire cohort in order to assess the gain in spectrometer - anatomopathology | 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 | J0 = intraoperative | 
| Attempt to create a microsteatosis prediction algorithm (version 3) using data from the global cohort | Agreement (intra-class correlation coefficient) between the percentage of microsteatosis estimated by the spectrometer and the microsteatosis quantified by the pathology | J0 = intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biopsy, macrosteatosis, spectrometry, liver transplantation, primary non-function