Observational Recruiting
NCT05106322 on ClinicalTrials.gov
Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
- Sponsor: Assistance Publique - Hôpitaux de Paris
- Enrollment: 240 (Estimated)
- Study start: 2022-01-14 (Actual)
- Primary completion: 2024-11-14 (Estimated)
- Study completion: 2024-11-14 (Estimated)
- Allocation: N/a
- InterventionModel: N/a
- Masking: None
- PrimaryPurpose: Other
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.
Conditions
- Liver Transplants
Intervention / Treatment
- Other: intraoperative spectrometer scan
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)
Countries
France
Locations and Investigators
-
Hôpital Beaujon, Clichy, France (Recruiting)
- François CAUCHY
- Hôpital Pitié-Salpetriere, Paris, France (Recruiting)
- Centre Hépato Biliaire de l'hopital Paul Brousse, Villejuif, France (Recruiting)
Study Officials
- Nicolas GOLSE (Principal Investigator) — APHP