Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy

描述(申请人提供)：前列腺癌是最常见的非皮肤病恶性肿瘤，是美国男性因癌症死亡的第二大原因。早期前列腺癌有可能通过放射治疗或手术治愈，也被称为根治性前列腺切除术。根治性前列腺切除术可以采用传统的、开放的方式，也可以在腹腔镜下进行。最近，使用达芬奇(R)手术机器人系统的机器人辅助的腹腔镜前列腺癌根治术(RALP)得到了广泛的接受。在前列腺癌根治术中保留包括海绵体神经在内的神经血管束(NVB)可促进术后性功能的恢复。然而，由于前列腺周围结缔组织和术中出血，NVB很难被观察到。多普勒超声可见NVB内伴行的动脉和静脉，可作为定位NVB内显微海绵状神经的宏观标志。使用经直肠超声(TRUS)的图像引导导航是指导RALP外科医生的一种新解决方案。研制了一种使用机器人超声探头机械手(TRUS Robot)的TRUS导引术中导航系统。这项拟议的研究是TRUS机器人和三维(3-D)导航软件的试点临床试验，以测试其在RALP期间帮助外科医生的图像引导能力。这是一种双机器人方法，即Tandem-Ralp(T-Ralp)。TRUS机器人允许对TRUS探头进行稳定握持和远程操作。此外，TRUS机器人可以跟踪TRUS探头的准确位置，从而实现图像的三维重建。在根治性前列腺切除术中使用TRUS成像可以潜在地改善NVB的可视化，从而改善男性术后的功能恢复。此外，前列腺的三维重建图像可以为外科医生提供清晰准确的手术标志指导。在这项快速试验中，同时使用TRUS Robot和3-D导航软件的T-Ralp方法的有效性和安全性将通过以下几个方面进行评估：1)评估神经血管束(NVB)预期位置与实际位置之间的距离；2)测量前列腺标志物之间的距离；3)量化包括直肠损伤在内的相关并发症的发生率。T-RALP入路的最终目标是改进前列腺癌的手术切除，同时更好地保留NVB并减少副作用。 公共卫生相关性：机器人辅助的腹腔镜前列腺癌根治术(RALP)是美国男性最常见的非皮肤癌前列腺癌的常见手术。我们建议使用一种新颖的机器人经直肠超声探头操作器(TRUS Robot)和三维(3-D)重建/导航软件，以使在RALP中使用TRUS进行图像导航。如果在这项快速试验中被证明是安全和有效的，在RALP期间使用基于TRUS的导航可以帮助精确切除含肿瘤的前列腺，改善神经血管束的保护，并减少相关的术后副作用。

DESCRIPTION (provided by applicant): Prostate cancer is the most common non-dermatologic malignancy and is the second leading cause of death due to cancer in men in the United States. Early stage prostate cancer is potentially cured by radiation therapy or surgery, also known as radical prostatectomy. Radical prostatectomy can be performed in a traditional, open fashion or laparoscopically. Recently, robot-assisted laparoscopic radical prostatectomy (RALP) using daVinci(R) surgical robot system has gained wide acceptance. The preservation of the neurovascular bundle (NVB) including cavernous nerves during radical prostatectomy improves the postoperative recovery of sexual potency. However, NVB can be difficult to visualize due to the periprostatic connective tissue and intraoperative hemorrhage. The accompanying arteries and veins in the NVB, which are visible with Doppler ultrasound, can serve as a macroscopic landmark to localize the microscopic cavernous nerves in the NVB. A new solution for guiding the surgeon in RALP is image-guided navigation using transrectal ultrasound (TRUS). A TRUS-guided intraoperative navigation system using a robotic ultrasound probe manipulator (TRUS Robot) has been developed. The proposed research is a pilot clinical trial of the TRUS Robot and three- dimensional (3-D) navigation software to test its image-guidance ability of helping the surgeon during RALP. This is a dual robot approach, a Tandem-RALP (T-RALP). The TRUS Robot allows a steady holding as well as remote manipulation of the TRUS probe. In addition, the TRUS Robot can track the accurate position of TRUS probe which allows 3-D reconstruction of the images. The use of TRUS imaging during radical prostatectomy can potentially improve the visualization of the NVB and subsequently improve postoperative recovery of potency in men. In addition, the 3-D reconstruction images of the prostate gland can provide clear and accurate guidance of surgical landmarks to the surgeon. In this quick trial, the efficacy and safety of the T-RALP approach of using both the TRUS Robot and 3-D navigation software will be evaluated by 1) assessing the distance between the expected versus true locations of neurovascular bundles (NVB), 2) measuring the distance between prostatic landmarks, and 3) quantifying the incidence of associated complications including rectal injury. The eventual goal of the T-RALP approach is to improve the surgical resection for prostate cancer while better preserving the NVB and reducing side effects. PUBLIC HEALTH RELEVANCE: Robot-assisted laparoscopic radical prostatectomy (RALP) is a commonly performed surgery for prostate cancer, the most common non-skin cancer in US men. We propose to use a novel, robotic transrectal ultrasound probe manipulator (TRUS Robot) and three-dimensional (3-D) reconstruction/navigation software to enable the intraoperative use of TRUS during RALP for image-guided navigation. If proven safe and effective in this quick trial, the use of TRUS-based navigation during RALP can be helpful for a precise resection of the tumor- containing prostate gland, the improved preservation of the neurovascular bundle and the decrease in associated postoperative side effects.