A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 694
- 试验地点
- 2
- 主要终点
- TRIFECTA score
研究概览
简要总结
The goal of this clinical trial is to evaluate peri and post-operative outcomes as well as long-term survival of 3D IGRAPN compared to conventional Robot-Assisted Partial Nephrectomy (RAPN) for moderate and highly complex renal tumors.
The main questions aim to answer:
- peri-operative complications
- oncological safety
- long term renal function Participants will be asked to do undergo 3D-IGRAPN. Researchers will compare 3D-IGRAPN to RAPN to see if peri-operative outcomes are better in the experimental group.
详细描述
Robot-assisted partial nephrectomy (RAPN) is the standard treatment for localized kidney tumors. New 3D modeling and reconstruction technologies have enabled the development of real time imageguided surgery using virtual reality (VR). In view of advances in artificial intelligence and surface recognition based on deep-learning, augmented reality (AR) by merging a 3D reconstructed virtual image onto the real per-operative view represents the next step in image-guided surgery.
3D IG-RAPN using Synapse 3D (Fujifilm) and DaVinci Tile-Pro display (Intuitive Surgical) vs conventional RAPN without 3D navigation in 12 high-volume urological centers from the UroCCR Network.
Outcoume : Primary endpoint is a composite validated score (TRIFECTA) evaluating peri-operative complications as well as oncological safety and long-term renal function preservation. Secondary endpoints assess long-term survival, ergonomics and surgeon satisfaction. A medico-economic evaluation will be performed.
Methodology: ACCURATE is a nation-wide, single-blind, multicentric, prospective randomized controlled trial enrolling 694 patients with a single complex renal mass, defined as RENAL NS≥7.
Randomization (1:1) between the experimental and the conventional group will take place on day of inclusion and will be stratified by center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
single blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years
- •Indication of RAPN for suspicious renal tumor
- •Moderate or high complexity renal tumor (RENAL Nephrometry Score (NS) >7)
- •Da Vinci® surgical system available for the surgery
- •Patient affiliated to the French social security system or an equivalent system
- •Signed informed consent form UroCCR and ACCURATE
排除标准
- •Medical contraindication to RAPN
- •Renal insufficiency forbidding iodine injection
- •Patient with allergy to iodinated contrast products
- •Patient concerned by articles L1121-5 to 8 of the French public health code (protected persons)
研究组 & 干预措施
conventional group
Robot-Assisted Partial Nephrectomy without 3D navigation
3D IGRAPN GROUP
Robot-Assisted Partial Nephrectomy with 3D navigation
干预措施: Robot assisted partial nephrectomy with 3D image guidance (Procedure)
结局指标
主要结局
TRIFECTA score
时间窗: 1 month
evaluating peri-operative outcome complications as well as oncological safety and long-term renal function preservation.
次要结局
- Overall survival(2 and 5 years)
- Amount of parenchyma preserved (according to CT scan)(Month 6)
- Blood loss(Intra-operatively)
- Warm ischemia time(Intra-operatively)
- Recurrence free survival(2 and 5 years)
- Number of Conversion to radical nephrectomy(Intraopertively)
- rate of Off clamp or superselective ischemia(Intraoperatively)
- Medico-economic evaluation(Month 1 and 6)
- NASA TLX(at the end of the surgery)