Image Guided Robotic Nephron-Sparing Surgery

图像引导机器人保留肾单位手术

• 批准号: 9242830
• 负责人: S Duke Herrell
• 金额: $ 34.71万
• 依托单位: VANDERBILT UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-01 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9242830
• 关键词: Acute; Address; Adopted; Anatomy; Blood Vessels; Cause of Death; Cessation of life; Chronic Disease; Clinical; Closure by clamp; Computer software; Data; Decision Making; Dimensions; Dissection; Ensure; Equipment; Evaluation; Excision; FDA approved; Fatty acid glycerol esters; Future; Goals; Health; Heart Diseases; Hemorrhage; Hospitals; Human; Image; Image-Guided Surgery; Incidence; Institutional Review Boards; Kidney; Kidney Failure; Kidney Neoplasms; Knowledge; Life; Maps; Measurement; Measures; Mechanics; Memory; Morbidity - disease rate; Multi-Institutional Clinical Trial; Nephrectomy; Nephrons; Operative Surgical Procedures; Optics; Organ; Outcome; Patients; Pilot Projects; Postoperative Period; Procedures; Process; Property; Psyche structure; Public Health; Quality of life; Renal carcinoma; Renal function; Research; Research Infrastructure; Risk; Robot; Robotics; Scanning; Series; Structure; Surface; Surgeon; System; Techniques; Technology; Testing; Time; Tissues; Translating; Urine; Validation; Vascular blood supply; Work; X-Ray Computed Tomography; base; comparative efficacy; efficacy study; experimental study; eye hand coordination; human subject; image guided; improved; in vivo; liver imaging; minimally invasive; mortality; prevent; programs; soft tissue; standard of care; statistics; success; three-dimensional modeling; tumor; validation studies

Project Summary The importance of preserving renal function during surgical interventions through nephron-sparing (“partial nephrectomy”) surgical techniques has garnered considerable and growing recent recognition. Total kidney removal (“radical nephrectomy”) permanently compromises renal function and leads to increased morbidity and mortality, with substantial negative impact on long-term patient quality of life. In contrast, partial nephrectomy improves long-term outcomes by sparing a maximal amount of healthy kidney tissue. However, minimally invasive partial nephrectomy is rarely attempted because it is extremely challenging to accomplish. The surgeon must make critical intraoperative decisions (which can mean life or death for the patient), based on imprecisely mentally inferred and registered three-dimensional anatomical relationships. The surgeon must view a series of 2D preoperative images and build a mental 3D model of patient anatomy. He/she must then intraoperatively guess how this remembered anatomical map should be registered to the patient. The inherent inaccuracies in this process prevent many surgeons from attempting minimally invasive partial nephrectomy, since positive margins (or inadvertent damage to internal kidney structures) are disastrous outcomes, while taking a large negative margin defeats the purpose of the partial nephrectomy procedure. Our overall goal is to create an image-guided surgical system that makes localization, dissection, and isolation of critical vascular and organ structures, as well as correct margin selection, easier and more accurate for the surgeon (and thus the procedure safer and more effective for the patient), thereby increasing the number of surgeons and hospitals able to adopt nephron sparing techniques. Toward this goal, our specific objective in this proposal is to test the hypothesis that image guidance can increase the accuracy and/or time- efficiency of the surgery. To test this hypothesis, we propose three Specific Aims: Aim 1 implements image guidance on the da Vinci surgical robot platform. Aim 2 addresses extensive phantom validation studies using anatomically accurate synthetic organs with realistic material properties. Aim 3 consists of an in vivo human subject pilot study we call a “bystander study” because it can be achieved with essentially zero risk to human subjects. The endpoint of this R01 will be a fully validated system, and the necessary experimental data to power a large-scale clinical comparative efficacy study. This study will be able to take place soon after the conclusion of this R01, due to the wide availability of the da Vinci robot, and the fact that all a surgeon or hospital must have to participate is the robot itself – no additional pieces of equipment or infrastructural changes will be necessary.

项目概要 在手术干预期间通过保留肾单位（“部分肾单位”）来保护肾功能的重要性 肾切除术”）手术技术最近已获得相当多的认可，并且越来越受到认可。全肾 肾切除术（“根治性肾切除术”）会永久损害肾功能并导致发病率增加和 死亡率，对患者的长期生活质量产生重大负面影响。相比之下，肾部分切除术 通过保留最大数量的健康肾组织来改善长期结果。然而，至少 很少尝试侵入性肾部分切除术，因为它实现起来极具挑战性。这 外科医生必须根据以下情况做出关键的术中决定（这可能意味着患者的生死） 不精确的心理推断和记录的三维解剖关系。外科医生必须 查看一系列 2D 术前图像并构建患者解剖结构的心理 3D 模型。那么他/她必须 术中猜测如何将所记住的解剖图注册给患者。固有的 这个过程中的不准确性阻止了许多外科医生尝试微创肾部分切除术， 因为正切缘（或对肾脏内部结构的无意损伤）是灾难性的结果，而 较大的负切缘违背了肾部分切除术的目的。 我们的总体目标是创建一个图像引导手术系统，可以进行定位、解剖和 关键血管和器官结构的分离，以及正确的切缘选择，更简单、更准确 对于外科医生来说（因此手术对患者来说更安全、更有效），从而增加了 能够采用肾单位保留技术的外科医生和医院的数量。为实现这一目标，我们具体 该提案的目的是测试图像引导可以提高准确性和/或时间的假设 手术的效率。为了检验这个假设，我们提出了三个具体目标： 目标 1 实现图像 达芬奇手术机器人平台的指导。目标 2 涉及广泛的模型验证研究，使用 具有真实材料特性的解剖学精确合成器官。目标 3 由活体人体组成 我们将主题试点研究称为“旁观者研究”，因为它可以在对人类基本零风险的情况下实现 科目。 R01 的终点将是一个经过充分验证的系统，以及必要的实验数据 为大规模临床比较疗效研究提供动力。这项研究将在 由于达芬奇机器人的广泛可用性，以及所有外科医生或 医院必须参与的是机器人本身——无需额外的设备或基础设施 改变是必要的。