Liver Transplants
Conditions
Keywords
macrosteatosis, spectrometry, liver transplantation, biopsy, primary non-function
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.
Interventions
OTHERintraoperative spectrometer scan
intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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% |
| 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 |
| 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) |
Countries
France
Outcome results
None listed