BMC cancer · 2025
Resection and partial liver transplantation from deceased donors with delayed total hepatectomy (RAPID procedure) for hepatocellular carcinoma: a national, multicenter, non-randomized, prospective trial.
Клиническое исследованиеСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Peloso Andrea, Pietrasz Daniel, Daillier Etienne, Cylly Laurent, Scatton Olivier, Goumard Claire, Mabrut Jean-Yves, Mohkam Kayvan, Lesurtel Mickael, Dokmak Safi, Jeddou Heithem, Boudjema Karim, Allard Marc-Antoine, Adam René, Sa Cunha Antonio, Azoulay Daniel, Cherqui Daniel, Vibert Eric, Golse Nicolas
Аннотация
BACKGROUND: This trial wants to ascertain whether the RAPID procedure could improve graft availability and patient survival in hepatocellular carcinoma (HCC) setting. RAPID-HCC trial, which aims to decrease waiting times and mortality for patients on the transplant list by adopting a novel surgical approach, could be a major step forward in liver transplantation (LT). If successful, the RAPID procedure could become a new standard of care for LT, addressing the critical shortage of organs and improving outcomes for selected patients with early-stage HCC. We expected to provide critical evidence to support the wider adoption of this new approach.
METHODS: The RAPID-HCC trial is a prospective, multicentre study conducted across five major university hospitals in France aiming to assess the feasibility, safety, tolerance, and efficacy of the RAPID procedure on HCC patients. A total of 50 adult HCC patients with preserved liver function (MELD score ≤ 15) will be enrolled and 34 of these will receive a split liver graft from a brain-dead donor (DBD). The RAPID procedure consists in splitting a deceased donor liver and transplanting it into two adult recipients. The operation consists of two phases: first, the donor's left lateral lobe (G23) replaces the recipient's left liver lobe (H1234), while the native right lobe stays to support hepatic function. The recipient's right lobe (H5678) is removed four months later, leaving the graft fully functional. Primary outcomes will focus on the feasibility and safety of the procedure, assessed by successful completion of both surgical stages and monitoring for adverse events. Secondary outcomes will include graft and patient survival, incidence of rejection and HCC recurrence, waiting times and overall patient outcomes compared to conventional whole liver transplantation.
DISCUSSION: Early insights from several studies hint that the RAPID method might improve graft availability and recipient survival. Still, further studies are needed to confirm these benefits, especially for HCC patients. RAPID HCC trial pushes forward liver transplants for HCC patients who still have good liver function. This method could reduce waiting times and mortality in transplant candidates. If successful, the RAPID procedure could be adopted as a new standard for LT. TRIAL REGISTRATION {2A} {2B}: ClinicalTrials.gov NCT05971628. Registered on August 2, 2023, before the start of inclusion. Project Code: APHP210351 / N° IDRCB: 2022-A02151-42.
GRANT SUPPORT: This study was supported by the French national PHRC-K Inca 2020.
METHODS: The RAPID-HCC trial is a prospective, multicentre study conducted across five major university hospitals in France aiming to assess the feasibility, safety, tolerance, and efficacy of the RAPID procedure on HCC patients. A total of 50 adult HCC patients with preserved liver function (MELD score ≤ 15) will be enrolled and 34 of these will receive a split liver graft from a brain-dead donor (DBD). The RAPID procedure consists in splitting a deceased donor liver and transplanting it into two adult recipients. The operation consists of two phases: first, the donor's left lateral lobe (G23) replaces the recipient's left liver lobe (H1234), while the native right lobe stays to support hepatic function. The recipient's right lobe (H5678) is removed four months later, leaving the graft fully functional. Primary outcomes will focus on the feasibility and safety of the procedure, assessed by successful completion of both surgical stages and monitoring for adverse events. Secondary outcomes will include graft and patient survival, incidence of rejection and HCC recurrence, waiting times and overall patient outcomes compared to conventional whole liver transplantation.
DISCUSSION: Early insights from several studies hint that the RAPID method might improve graft availability and recipient survival. Still, further studies are needed to confirm these benefits, especially for HCC patients. RAPID HCC trial pushes forward liver transplants for HCC patients who still have good liver function. This method could reduce waiting times and mortality in transplant candidates. If successful, the RAPID procedure could be adopted as a new standard for LT. TRIAL REGISTRATION {2A} {2B}: ClinicalTrials.gov NCT05971628. Registered on August 2, 2023, before the start of inclusion. Project Code: APHP210351 / N° IDRCB: 2022-A02151-42.
GRANT SUPPORT: This study was supported by the French national PHRC-K Inca 2020.