Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Evaluate the concordance between the macrosteatosis quantified by the pocket spectrometer and the macrosteatosis content evaluated by the standard pathological analysis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Evaluate the concordance between the macrosteatosis quantified by the pocket spectrometer and the macrosteatosis content evaluated by the standard pathological analysis
时间窗: 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)
次要结局
- Evaluation of the potential impact of spectrometer results on the surgeon's decision to accept the graft using simulated results(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"(J0 = intraoperative)
- Evaluation of the spectrometer performance for diagnosis to detect macrosteatosis> 30% and> 60% taking the pathology as a reference standard(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)(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(J0 = intraoperative)
- Assessment of the concordance between the macrosteatosis visually assessed by the harvesting surgeon and the definitive pathological data(J0 = intraoperative)
- Attempt to create a microsteatosis prediction algorithm (version 3) using data from the global cohort(J0 = intraoperative)