Margue Gaëlle, Bernhard Jean-Christophe, Giai Joris, Bouzit Assilah, Ricard Solène, Jaffredo Manon, Guillaume Bénédicte, Jambon Eva, Fiard Gaëlle, Bigot Pierre, Waeckel Thibaut, Surlemont Louis, Vergie Stéphane De, Branger Nicolas, Doumerc Nicolas, Boissier Romain, Lang Hervé, Audenet François, Beauval Jean-Baptiste, Bensalah Karim, Descazeaud Aurelien, David-Tchouda Sandra, Richert Laura, Long Jean-Alexandre, Descotes Jean-Luc
Bordeaux University Hospital, Bordeaux, France; I-CaRe, Inserm U1312 BRIC, Bordeaux, France; Kidney Cancer Group of the French Association of Urology Cancer Committee, France.
Bordeaux University Hospital, Bordeaux, France; I-CaRe, Inserm U1312 BRIC, Bordeaux, France; Kidney Cancer Group of the French Association of Urology Cancer Committee, France.
Eur Urol Oncol. 2025 Apr 7. doi: 10.1016/j.euo.2025.03.012.
Renal cancer often requires nephron-sparing surgery for optimal patient outcomes. Despite advances in imaging and robot-assisted surgery, there is a need to enhance surgical precision and renal preservation. This trial evaluates the effectiveness of three-dimensional image-guided robot-assisted partial nephrectomy versus standard methods in improving surgical outcomes.
This trial is a prospective, 1:1 randomized, single-blind phase 3 superiority study conducted across 14 centers within the French Network for Research on Kidney Cancer, aiming to enroll 694 patients over 36 mo.
The primary endpoint is a composite trifecta score, including negative surgical margins, no complications, and renal function preservation (estimated glomerular filtration rate >90% at 1 mo). The secondary endpoints include oncological outcomes, conversion rates, perioperative parameters, and economic evaluation.
Data are collected via the UroCCR database. Logistic regression will analyze the primary endpoint, and various regression methods will address the secondary outcomes. Economic evaluations involve incremental cost-utility and cost-effectiveness ratios.
Strengths include the multicenter design and robust randomization. Limitations involve variability in surgeons' experience with the new three-dimensional technology and logistical challenges in technology adoption.
This clinical trial is designed to evaluate a new surgical technique for treating kidney tumors called three-dimensional (3D) image-guided robot-assisted partial nephrectomy. This study aims to determine whether this new method is more effective and safer than the current standard robot-assisted surgery by improving surgical precision and preserving kidney function. Kidney tumors require precise surgical removal to ensure the best outcomes for patients both during and after surgery. While robotic assistance has improved many surgeries, use of advanced 3D imaging during these procedures might enhance the surgeon's ability to operate with greater accuracy, potentially leading to better patient outcomes and fewer complications. Participants in the trial will undergo surgery using either the conventional robotic-assisted method or the new 3D image-guided technique. The method used for each participant will remain undisclosed to maintain the study's integrity. All participants will receive the highest standard of care, and their progress will be monitored closely throughout the trial. This study hopes to demonstrate that the 3D image-guided method can improve surgical precision and outcomes for patients undergoing kidney tumor removal. If successful, this technique could set a new standard for kidney surgery and improve the overall care patients receive in the future. The addition of 3D reconstruction to the surgery carries very little extra risk. If any technical issues occur, the surgeons can switch back to the regular method without affecting safety. The 3D technology we use, Synapse 3D, is approved and used in hospitals worldwide, ensuring that its safety is well proven by existing evidence.
肾癌通常需要进行保留肾单位手术以实现最佳的患者预后。尽管在影像学和机器人辅助手术方面取得了进展，但仍有必要提高手术精度并更好地保留肾脏。本试验评估三维图像引导机器人辅助部分肾切除术与标准方法相比在改善手术效果方面的有效性。
本试验是一项前瞻性、1:1随机、单盲3期优效性研究，在法国肾癌研究网络的14个中心开展，旨在在36个月内招募694例患者。
主要终点指标是综合三联指标评分，包括手术切缘阴性、无并发症以及肾功能保留（术后1个月时估计肾小球滤过率>90%）。次要终点指标包括肿瘤学结局、转化率、围手术期参数以及经济学评估。
数据通过UroCCR数据库收集。将采用逻辑回归分析主要终点指标，采用多种回归方法分析次要结局。经济学评估涉及增量成本效用比和成本效益比。
优势包括多中心设计和严格的随机化。局限性包括外科医生对新三维技术的经验差异以及技术应用中的后勤挑战。
本临床试验旨在评估一种治疗肾肿瘤的新手术技术，即三维（3D）图像引导机器人辅助部分肾切除术。本研究旨在确定这种新方法通过提高手术精度和保留肾功能是否比当前的标准机器人辅助手术更有效、更安全。肾肿瘤需要精确的手术切除以确保患者在手术期间及术后获得最佳预后。虽然机器人辅助改善了许多手术，但在这些手术过程中使用先进的3D成像可能会提高外科医生的操作准确性，有可能带来更好的患者预后并减少并发症。试验参与者将采用传统机器人辅助方法或新的3D图像引导技术进行手术。为保持研究的完整性，每位参与者所采用的方法将不予披露。所有参与者都将接受最高标准的护理，并且在整个试验过程中其进展将受到密切监测。本研究希望证明3D图像引导方法能够提高接受肾肿瘤切除术患者的手术精度和预后。如果成功，这项技术可能会为肾脏手术树立新的标准，并改善患者未来接受的整体护理。手术中增加3D重建带来的额外风险极小。如果出现任何技术问题，外科医生可以切换回常规方法而不影响安全性。我们使用的3D技术Synapse 3D已获得全球医院的批准并投入使用，确保其安全性已得到现有证据的充分证明。
