Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Liver Transplants Clinical Trial

— iGRAISSE  

Official title:

Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05106322
• Other study ID #: APHP210949
• Status: Not yet recruiting
• Start date: January 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: October 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Transplants

Intervention

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

Locations

Country	Name	City	State
France	Centre Hépato Biliaire de l'hopital Paul Brousse	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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