Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

NCT05106322 | Recruiting

• 1 other identifier: APHP210949
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Liver Transplants

Keywords

macrosteatosis; spectrometry; liver transplantation; biopsy; primary non-function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• Evaluation of the potential impact of spectrometer results on the surgeon's decision to accept the graft using simulated results

  J0 = intraoperative

Study Arms (1)

Liver transplants

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

Other: intraoperative spectrometer scan

Interventions

intraoperative spectrometer scan OTHER

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

Liver transplants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Centre Hépato Biliaire de l'hopital Paul Brousse

Villejuif, 94800, France

RECRUITING

Hôpital Beaujon

Clichy, Île-de-France Region, 92110, France

RECRUITING

Hôpital Pitié-Salpetriere

Paris, Île-de-France Region, 75013, France

RECRUITING

Study Officials

• Nicolas GOLSE

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 3, 2021
• Study Start: January 14, 2022
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)