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

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ClinicalTrials.gov Identifier: NCT05106322
Recruitment Status : Not yet recruiting
First Posted : November 3, 2021
Last Update Posted : November 3, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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.


Condition or disease Intervention/treatment
Liver Transplants Other: intraoperative spectrometer scan

Study Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : November 1, 2024
Estimated Study Completion Date : November 1, 2024

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluate the concordance between the macrosteatosis quantified by the pocket spectrometer and the macrosteatosis content evaluated by the standard pathological analysis [ Time Frame: 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 Outcome Measures :
  1. Evaluation of the spectrometer performance for diagnosis to detect macrosteatosis> 30% and> 60% taking the pathology as a reference standard [ Time Frame: J0 = intraoperative ]
    Area under the ROC curve (AUC), sensitivity, specificity, likelihood ratio and predictive values of the spectrometer to detect macrosteatosis> 30% and> 60%

  2. Assessment of the technical feasibility of using the spectrometer in daily practice, analysis of the causes and incidence of failures (technical or organizational) [ Time Frame: 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.

  3. 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 [ Time Frame: 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).

  4. Assessment of the concordance between the macrosteatosis visually assessed by the harvesting surgeon and the definitive pathological data [ Time Frame: 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 )

  5. Evaluation of the potential impact of spectrometer results on the surgeon's decision to accept the graft using simulated results [ Time Frame: 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)

  6. Modification and improvement of the current algorithm based on the spectra of the entire cohort in order to assess the gain in "spectrometer - anatomopathology" [ Time Frame: 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

  7. Attempt to create a microsteatosis prediction algorithm (version 3) using data from the global cohort [ Time Frame: J0 = intraoperative ]
    Agreement (intra-class correlation coefficient) between the percentage of microsteatosis estimated by the spectrometer and the microsteatosis quantified by the pathology


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05106322


Locations
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France
Centre Hépato Biliaire de l'hopital Paul Brousse
Villejuif, France, 94800
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Nicolas GOLSE APHP
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05106322    
Other Study ID Numbers: APHP210949
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: November 3, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
macrosteatosis
spectrometry
liver transplantation
biopsy
primary non-function
Additional relevant MeSH terms:
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Fatty Liver
Liver Diseases
Digestive System Diseases