Liver TransplantsiGRAISSENCT05106322
Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
An observational study of Liver Transplants, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplants
- What is being tested?
- intraoperative spectrometer scan
- How many people
- 240 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Jan 2022to 14 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Whole liver transplants proposed for organ harvesting from brain-dead donors assigned by the Biomedicine Agency
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital Beaujon
Clichy, Île-de-France Region, 92110
François CAUCHY, 01 40 87 58 95, françois.cauchy@aphp.fr
- Recruiting
Hôpital Pitié-Salpetriere
Paris, Île-de-France Region, 75013
Claire GOUMARD, 01 42 17 56 21, claire.goumard@aphp.fr
- Recruiting
Centre Hépato Biliaire de l'hopital Paul Brousse
Villejuif, 94800
Nicolas GOLSE, 06 71 28 24 03 ext. +33, nicolas.golse@aphp.fr
About this study
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
- Being tested
- intraoperative spectrometer scan
- Keywords
- macrosteatosis, spectrometry, liver transplantation, biopsy, primary non-function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative spectrometer scanOther
intraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta
| Study group | Role | What they receive |
|---|---|---|
| Liver transplants | Whole liver transplants proposed for organ harvesting from brain-dead donors and assigned by the Biomedicine Agency. Receives: Other: intraoperative spectrometer scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Area under the ROC curve (AUC), sensitivity, specificity, likelihood ratio and predictive values of the spectrometer to detect macrosteatosis> 30% and> 60%
Measured: 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)
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.
Measured: 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
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).
Measured: J0 = intraoperative
Assessment of the concordance between the macrosteatosis visually assessed by the harvesting surgeon and the definitive pathological data
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 )
Measured: J0 = intraoperative
Evaluation of the potential impact of spectrometer results on the surgeon's decision to accept the graft using simulated results
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)
Measured: J0 = intraoperative
Modification and improvement of the current algorithm based on the spectra of the entire cohort in order to assess the gain in "spectrometer - anatomopathology"
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
Measured: J0 = intraoperative
Attempt to create a microsteatosis prediction algorithm (version 3) using data from the global cohort
Agreement (intra-class correlation coefficient) between the percentage of microsteatosis estimated by the spectrometer and the microsteatosis quantified by the pathology
Measured: J0 = intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start14 Jan 2022
- Primary completion14 Nov 2024 (estimated)
- Study completion14 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas GOLSE, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106322
- Sponsor's protocol ID
- APHP210949
- Acronym
- iGRAISSE
- Status last verified
- Jun 2024
- First submitted
- 22 Oct 2021
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Steatosis on Liver Transplants by Intraoperative Spectrometry
- ClinicalTrials.gov ID
- NCT05106322
- Acronym / sponsor ID
- iGRAISSE / APHP210949
- Conditions
- Liver Transplants
- Keywords
- macrosteatosis, spectrometry, liver transplantation, biopsy, primary non-function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 14 Nov 2024 (estimated)
- Study completion
- 14 Nov 2024 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplants | – | Other: intraoperative spectrometer scanWhole liver transplants proposed for organ harvesting from brain-dead donors and assigned by the Biomedicine Agency. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Whole liver transplants proposed for organ harvesting from brain-dead donors assigned by the Biomedicine Agency
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative spectrometer scanintraoperative spectrometer scan (five scans on the left lobe) before clamping the aorta | Other | Liver transplants |
Primary outcome
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)
7 secondary outcomes
Evaluation of the spectrometer performance for diagnosis to detect macrosteatosis> 30% and> 60% taking the pathology as a reference standard
Time frame: 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)
Time frame: 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
Time frame: J0 = intraoperative
Assessment of the concordance between the macrosteatosis visually assessed by the harvesting surgeon and the definitive pathological data
Time frame: J0 = intraoperative
Evaluation of the potential impact of spectrometer results on the surgeon's decision to accept the graft using simulated results
Time frame: J0 = intraoperative
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
Attempt to create a microsteatosis prediction algorithm (version 3) using data from the global cohort
Time frame: J0 = intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centre Hépato Biliaire de l'hopital Paul Brousse
Villejuif, France
Nicolas GOLSE principal investigator
APHP
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplants, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2024.