Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy

描述（由申请人提供）：前列腺癌是最常见的非皮肤恶性肿瘤，是美国男性癌症死亡的第二大原因。早期前列腺癌可能通过放射治疗或手术治愈，也称为根治性前列腺切除术。根治性直肠癌切除术可以在传统的，开放的方式或腹腔镜下进行。最近，使用达芬奇（R）手术机器人系统的机器人辅助腹腔镜根治性直肠癌切除术（RALP）已获得广泛接受。在根治性尿道切除术中保留包括海绵体神经在内的神经血管束（NVB）可提高术后性能力的恢复。然而，由于前列腺周围结缔组织和术中出血，NVB可能难以可视化。多普勒超声可见的NVB中的伴随动脉和静脉可以作为定位NVB中微观海绵状神经的宏观标志。在RALP中引导外科医生的新解决方案是使用经直肠超声（TRUS）的图像引导导航。已经开发了一种使用机器人超声探头操纵器（TRUS Robot）的TRUS引导术中导航系统。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。这是双机器人方法，串联RALP（T-RALP）。TRUS机器人允许稳定固定以及远程操纵TRUS探头。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成像可能会改善NVB的可视化，从而改善男性术后的性功能恢复。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。在这项快速试验中，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方式进行评估：1）评估神经血管束（NVB）的预期位置与真实位置之间的距离，2）测量前列腺标志之间的距离，以及3）量化相关并发症（包括直肠损伤）的发生率。T-RALP方法的最终目标是改善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：机器人辅助腹腔镜根治性前列腺癌切除术（RALP）是一种常见的前列腺癌手术，前列腺癌是美国男性最常见的非皮肤癌。我们建议使用一种新型的机器人经直肠超声探头操纵器（TRUS机器人）和三维（3-D）重建/导航软件，以便在RALP期间术中使用TRUS进行图像引导导航。如果在这项快速试验中证明安全有效，RALP期间使用基于TRUS的导航有助于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.