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This is a national, non-randomized, multicentric trial evaluating the feasibility and the tolerance of the RAPID procedure in patients with HCC with preserved liver function requiring a liver transplantation.
In France, the liver transplant allocation is based on the severity of liver failure, but patients with hepatocellular carcinoma (HCC) usually do not have hepatocellular failure, resulting in reduced access to liver transplantation. Two years after registration on the LT list, only 66% of those registered are transplanted due to tumor progression. This observation leads to the paradoxical conclusion that better access to transplantation is an absolute priority, but remains limited by the shortage of grafts.
The split surgical of one graft into two grafts is the most effective way to increase the number of transplantable organs. This technique is performed daily as part of pediatric TH where the child receives the left lobe/liver, adapted to his morphology. However, in adults, transplantation of the left lobe (segments 2+3) or of the left liver (segments 2+3+4) associated with complete excision of the native liver generates a high rate of complications (small-for-size syndrome) and compromises graft and recipient survival. For these reasons, this type of procedure has been almost abandoned in France.
One of the ways to increase the organ pool without risking liver failure is therefore to perform an auxiliary transplant with a partial graft from an organ harvested in its entirety and then shared.
The investigators therefore wish to evaluate the feasibility and tolerance, the results and the "gain" of grafts after a standardized RAPID procedure ( Resection And Partial LIver Transplantation with Delayed Hepatectomy) allowing to transplant an adult with a left lobe (very small graft) from a shared whole graft (deceased donor in brain death) , and to compare the results with standard management (orthotopic HT with whole organ for HCC).
The population is 50 major patients (in order to realize the RAPID procedure for 34 patients) with HCC requiring LT according to the usual transplantability criteria, with preserved liver function. The study lasts a maximum of 70 months (24 months of inclusion period, 6 months between selection and inclusion, <12 months between inclusion and the 1st RAPID time, 4 months maximum between the 2 RAPID Steps, 24 months of patient follow-up post 2nd step of RAPID). The study will proceed as described below :
The expected benefits for participants are :
The expected benefits for society are :
The risks added by research :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver transplantation with the RAPID procedure | Experimental | Liver transplantation for hepatocellular carcinoma according to the RAPID protocol. This protocol is an auxiliary liver transplantation of a partial graft with total hepatectomy in two stages (2 successive operations). |
|
| Comparator group with standard liver transplantation (whole graft) | No Intervention | Orthotopic liver transplantation with whole organ from deceased donor for hepatocellular carcinoma. Data will be provided by Biomedicine Agency, following pairing rules. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAPID procedure | Procedure | RAPID procedure stands for Resection And Partial Liver Transplantation with Delayed Hepatectomy for hepatocellular carcinoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patient with successful RAPID procedure | Success of the procedure will be assessed as a patient :
| 4 months after the second RAPID step |
| Tolerance of the RAPID procedure | Tolerance will be assessed with Adverse events related to the procedure | from first stage of the surgical protocol and until 90 days after the second stage |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of grafts in place | Number of patients with a graft in place at 4 months after the first surgical step | 4 months after the first surgical step |
| Survival of grafts at 2 years from liver transplantation (LT) |
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Inclusion criteria (RAPID receiver)
Exclusion criteria
Donor selection criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas GOLSE, Doctor | Contact | 3306 71 28 24 03 | nicolas.golse@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas GOLSE, Doctor | APHP, Paul Brousse Hospital, villejuif, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Paul Brousse Hospital | Villejuif | 94800 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40346479 | Derived | Peloso A, Pietrasz D, Daillier E, Cylly L, Scatton O, Goumard C, Mabrut JY, Mohkam K, Lesurtel M, Dokmak S, Jeddou H, Boudjema K, Allard MA, Adam R, Sa Cunha A, Azoulay D, Cherqui D, Vibert E, Golse N. Resection and partial liver transplantation from deceased donors with delayed total hepatectomy (RAPID procedure) for hepatocellular carcinoma: a national, multicenter, non-randomized, prospective trial. BMC Cancer. 2025 May 9;25(1):848. doi: 10.1186/s12885-025-14127-7. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Survival RAPID grafts considered in the event of a graft still in place Non-survival in the event of the patient's death or new LT
| at 2 Years from LT |
| Survival of patient at 2 year after their registration on the waiting list of transplantation | whatever the cause of death | at 2 year after their registration on the waiting list of transplantation |
| Survival of patient at 2 year after LT | at 2 year after LT |
| Incidence of rejection after RAPID | Identification of histologically proven rejections within 2 years after the first stage of RAPID. | at 2 years after the first stage of RAPID |
| Waiting time between listing on the waiting list and LT according to RAPID | Time between registration the waiting list and TH according to RAPID (1st step) | 1 year |
| Gain of grafts | Number of left lobes transplanted according to RAPID protocol - the number of retransplantations = organ gain obtained. Will be also analysed, the number of right livers generated and transplanted, as well as the number of complete RAPID procedures (native liver excision) will also be analyzed. | 70 months |
| Comparison of the drop-out rate between RAPID group and control group | Drop out will be estimated by exclusion from the LT program, whatever the cause : death, worsening, transplant refusal, etc. | 18 months |
| Comparison of the waiting time between registration on the transplantation list and LT between RAPID group and control group | Patients who completed the 1st RAPID phase compared to the control group | up to 18 months |
| Comparison of the graft survival at 2 years after LT between RAPID group and control group | at 2 years after 1rst stage of RAPID |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |