Actively Recruiting

Age: 18Years +
All Genders
NCT05106322

Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-06-26

240

Participants Needed

3

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Brain-dead donor
  • Age �3E�3D 18 years old
  • No restriction from donor or family regarding use of data for research
  • No fibrous appearance of the graft (visual assessment), corresponding to Metavir score �3C F2
Not Eligible

You will not qualify if you...

  • Living donor

  • Donor within Maastricht III criteria (cardiac arrest)

  • Pre-existing liver injury or trauma preventing intraoperative use of the pocket spectrometer

  • History of supra-mesocolic surgery or peritonitis causing perihepatic adhesions (preventing use of pocket spectrometer)

  • History of chemotherapy or biological cholestasis with:

  • GGT �3E 400 IU/L

  • or total bilirubin �3E 60 micromol/L

  • or conjugated bilirubin �3E 30 micromol/L

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Centre Hépato Biliaire de l'hopital Paul Brousse

Villejuif, France, 94800

Actively Recruiting

2

Hôpital Beaujon

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

Actively Recruiting

3

Hôpital Pitié-Salpetriere

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

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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