Using a pocket-sized spectrometer to assess liver fat during transplants
Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
Assistance Publique - Hôpitaux de Paris · NCT05106322
This study is testing a small device that helps doctors check the fat content in liver transplants to see if it can improve how they evaluate the quality of the liver before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Villejuif and 2 other locations) |
| Trial ID | NCT05106322 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of a portable spectrometer for assessing macrosteatosis in liver transplants during the harvesting process. Surgeons will perform intraoperative scans on the liver graft before clamping the aorta, without being informed of the results, to ensure unbiased decision-making regarding biopsies. The spectrometer's findings will be compared to definitive histological results to determine its reliability and accuracy. The goal is to provide a minimally invasive and cost-effective tool that can enhance the evaluation of liver graft quality.
Who should consider this trial
Good fit: Ideal candidates for this study are brain-dead donors aged 18 and older with no fibrous appearance of the graft.
Not a fit: Patients who are living donors or have a history of significant hepatic injury or trauma will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved selection of liver grafts, reducing the risk of primary non-function and enhancing transplant outcomes.
How similar studies have performed: While the use of spectrometry in this context is innovative, similar studies have shown promise in non-invasive assessments of graft quality, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Villejuif and 2 other locations
- Centre Hépato Biliaire de l'hopital Paul Brousse — Villejuif, France (RECRUITING)
- Hôpital Beaujon — Clichy, Île-de-France Region, France (RECRUITING)
- Hôpital Pitié-Salpetriere — Paris, Île-de-France Region, France (RECRUITING)
Study contacts
- Principal investigator: Nicolas GOLSE — APHP
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Liver Transplants, macrosteatosis, spectrometry, liver transplantation, biopsy, primary non-function