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
Hepato-Biliary Center, Paul-Brousse Hospital, Assistance Publique-Hôpitaux de Paris, Villejuif, Paris, France.
Department of Surgery, Division of Abdominal Surgery and Transplantation, Geneva University Hospitals and Faculty of Medicine, Geneva, Switzerland.
BMC Cancer. 2025 May 9;25(1):848. doi: 10.1186/s12885-025-14127-7.
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.
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.
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.
This study was supported by the French national PHRC-K Inca 2020.
本试验旨在确定RAPID手术能否提高肝细胞癌（HCC）患者的移植物可用性和患者生存率。RAPID-HCC试验旨在通过采用一种新的手术方法来减少移植等待名单上患者的等待时间和死亡率，这可能是肝移植（LT）向前迈出的重要一步。如果成功，RAPID手术可能成为LT的新护理标准，解决器官严重短缺问题，并改善部分早期HCC患者的治疗结果。我们期望提供关键证据以支持这种新方法的更广泛应用。
RAPID-HCC试验是一项前瞻性、多中心研究，在法国的五家主要大学医院进行，旨在评估RAPID手术对HCC患者的可行性、安全性、耐受性和疗效。总共将招募50例肝功能良好（终末期肝病模型评分≤15）的成年HCC患者，其中34例将接受来自脑死亡供体（DBD）的劈离式肝移植。RAPID手术包括将已故供体肝脏劈离并移植到两名成年受者体内。手术包括两个阶段：首先，供体的左外侧叶（G23）替换受者的左肝叶（H1234），而受者的右肝叶保留以维持肝功能。四个月后切除受者的右肝叶（H5678），使移植物完全发挥功能。主要结局将聚焦于手术的可行性和安全性，通过两个手术阶段的成功完成以及不良事件监测来评估。次要结局将包括移植物和患者生存率、排斥反应和HCC复发的发生率、等待时间以及与传统全肝移植相比的总体患者结局。
多项研究的早期见解表明，RAPID方法可能会提高移植物可用性和受者生存率。不过，仍需进一步研究来证实这些益处，尤其是对于HCC患者。RAPID HCC试验推动了对肝功能仍良好的HCC患者进行肝移植。这种方法可以减少移植候选者的等待时间和死亡率。如果成功，RAPID手术可被采纳为LT的新标准。试验注册：ClinicalTrials.gov NCT05971628。于2023年8月2日在纳入开始前注册。项目代码：APHP210351 / IDRCB编号：2022 - A02151 - 42。
本研究由法国国家PHRC - K Inca 2020资助。
