Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry (iGRAISSE)

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Transplants
• Intervention / Treatment: Other: intraoperative spectrometer scan

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

Study Locations

• France
  • Villejuif, France, 94800
    • Recruiting
    • Centre Hépato Biliaire de l'hopital Paul Brousse
    • Contact: Nicolas GOLSE; Phone Number: +33 06 71 28 24 03; Email: nicolas.golse@aphp.fr
  • Ile De France
    • Clichy, Ile De France, France, 92110
      • Recruiting
      • Hopital Beaujon
      • Contact: François CAUCHY; Phone Number: 01 40 87 58 95; Email: françois.cauchy@aphp.fr
    • Paris, Ile De France, France, 75013
      • Recruiting
      • Hôpital Pitié-Salpêtrière
      • Contact: Claire GOUMARD; Phone Number: 01 42 17 56 21; Email: claire.goumard@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Whole liver transplants proposed for organ harvesting from brain-dead donors assigned by the Biomedicine Agency

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nicolas GOLSE, APHP

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Estimated): November 14, 2024
• Study Completion (Estimated): November 14, 2024

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: liver transplantation; primary non-function; biopsy; macrosteatosis; spectrometry
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: APHP210949

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No