NCT05106322 Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
| NCT ID | NCT05106322 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Liver Transplants |
| Study Type | OBSERVATIONAL |
| Enrollment | 240 participants |
| Start Date | 2022-01-14 |
| Primary Completion | 2024-11-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 240 participants in total. It began in 2022-01-14 with a primary completion date of 2024-11-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Nicolas GOLSE
PRINCIPAL INVESTIGATOR
APHP
Frequently Asked Questions
Who can join the NCT05106322 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Transplants. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05106322 currently recruiting?
Yes, NCT05106322 is actively recruiting participants. Visit ClinicalTrials.gov or contact Assistance Publique - Hôpitaux de Paris to inquire about joining.
Where is the NCT05106322 trial being conducted?
This trial is being conducted at Villejuif, France, Clichy, France, Paris, France.
Who is sponsoring the NCT05106322 clinical trial?
NCT05106322 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Nicolas GOLSE at APHP. The trial plans to enroll 240 participants.