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

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

Tracking Information

• First Submitted Date: October 22, 2021
• First Posted Date: November 3, 2021
• Last Update Posted Date: November 3, 2021
• Estimated Study Start Date: January 1, 2022
• Estimated Primary Completion Date: November 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 22, 2021)

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)

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 22, 2021)

• 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%
• 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.
• 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).
• 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 )
• 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)
• 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
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
• Official Title: Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Whole liver transplants proposed for organ harvesting from brain-dead donors assigned by the Biomedicine Agency
• Condition: Liver Transplants

Intervention

Other: intraoperative spectrometer scan

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

Study Groups/Cohorts

Liver transplants

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

Intervention: Other: intraoperative spectrometer scan

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: October 22, 2021): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 1, 2024
• Estimated Primary Completion Date: November 1, 2024 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT05106322
• Other Study ID Numbers: APHP210949
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Assistance Publique - Hôpitaux de Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Assistance Publique - Hôpitaux de Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Nicolas GOLSE; APHP

• PRS Account: Assistance Publique - Hôpitaux de Paris
• Verification Date: October 2021