Development and Validation of a Virtual Endoluminal Surgical Simulator (VESS) for Treatment of Colorectal Cancer

虚拟腔内手术模拟器(VESS)的研制与验证 结直肠癌 摘要 结直肠癌(CRC)是美国男性和女性第三常见的癌症， 癌症相关死亡的第二大原因。然而，早期诊断和治疗是关键因素。 提高存活率。在美国，使用内窥镜的非常积极的筛查计划已经到位，以减少结直肠癌。 随着介入性内窥镜的发展，切除大肠息肉和结直肠息肉的手术有增加的趋势。 早期结直肠癌的内窥镜下使用通过工作通道推进的小型灵活工具 内窥镜检查。内窥镜治疗是微创的，具有一定的优势，包括更快 与传统方法相比，康复、住院时间短、费用低、术后生活质量好 肠道手术。传统的使用圈套的息肉切除术对带蒂肿瘤(细长的)很有效 有柄的肿瘤)，但对于无柄或扁平的肿瘤就不是这样了，不幸的是，这两种肿瘤的风险更高 癌症。对于这类肿瘤，已经发展了内窥镜黏膜切除术(EMR)技术。 然而，对于较大的肿瘤(&gt；2 cm)，EMR存在并发症和完全清除的风险(整体 切除)可能无法实现，导致复发和肿瘤残留的高风险。内窥镜检查 黏膜下剥离术(ESD)是一种可以完全切除和治愈的技术。 肿瘤没有大小限制，导致精确的组织病理学边缘和低得多的复发率 在长期的随访中。在这项可以在轻度镇静下进行的技术中，注射一种液体 在病变的下面，然后用一把专门的刀把粘膜下层切开。然而， 由于结直肠壁薄且不断移动，执行结直肠ESD在技术上要求很高。 蠕动可以改变进入病变部位的途径，而急转弯可以进一步限制进入。因此，一个 至少需要50-100例病例，以将术中并发症(如出血)的发生率降至最低 和穿孔)，并达到基本熟练。 预计基于虚拟现实(VR)、具有视觉和触觉(触摸)反馈的训练器将是 ESD培训的宝贵价值，使学员能够在受控环境中获得能力，而不会有任何风险 提供给患者；个性化学习；以及实时反馈、指导和客观评估。的目标是 本文的目的是设计、开发和验证一个虚拟腔内手术模拟器 (VESS)，可用于培训ESD内窥镜医生。这样的模拟器将在培训 各种其他粘膜下外科手术(例如，经口腔内窥镜肌切开术、内窥镜手术 功能性和动力障碍的诊断及经口经胃腹膜和腹膜入路 纵隔)，其目的是为了治疗而不是切除肿瘤。一个 组建了多学科团队，以实现以下具体目标：(SA 1)设计和 虚拟腔内手术模拟器(VESS)平台的开发 内窥镜手术。具体地说，我们将开发(1)基于物理的人类计算模型 基于活体实验研究的解剖学；(2)触觉硬件接口。(SA 2)开展培训 鼻内窥镜下黏膜下剥离术(ESD)在VESS中的应用 性能反馈。具体地说，我们将(I)整合计算模型和活体实验 来自SA1的数据，为ESD开发实践技能培训环境，使受训人员能够执行 替代方法和遇到典型陷阱的后果，以及(Ii)产生业绩 反馈模块，用于向学习者提供形成性和总结性反馈。(SA 3)确立效力 通过在贝丝以色列女执事医疗中心进行实验，将Vess作为培训工具 自愿从波士顿当地医学院和教学医院招募的受试者，以确保 在VESS上学习适当的技能，在VESS上测量的表现反映了技术 他们打算衡量的技能。

Development and Validation of a Virtual Endoluminal Surgery Simulator (VESS) for the Treatment of Colorectal Cancer Abstract Colorectal cancer (CRC) is the third most common cancer for both men and women in the United States and the second leading cause of cancer related deaths. However, early diagnosis and treatment are key factors to improve survival. In the US, a very active screening program using endoscopy is in place for CRC reduction. With advancement in interventional endoscopy, there is an increasing trend to resect colorectal polyp and early colorectal cancer endoscopically using small flexible tools advanced through the working channel of the endoscope. Endoscopic treatment is minimally invasive that offers certain advantages including faster recovery, shorter hospital stay, low cost and better postoperative quality of life compared with traditional intestinal surgery. Traditional polypectomy using a snare works well for pedunculated tumors (elongated tumors with a stalk), but not so much for sessile or flat tumors, which, unfortunately, carry a higher risk of cancer. For such tumors, the endoscopic mucosal resection (EMR) technique has been developed. However, for large tumors (>2cm) EMR carries risk of complications and complete clearance (en-bloc resection) may not be achievable leading to high risk of recurrence and residual tumor. Endoscopic Submucosal Dissection (ESD) is a technique that allows complete en-bloc resection and possible cure of tumors without size limitations, leading to precise histopathological margins and a much lower recurrence rate at long-term follow-ups. In this technique, which can be performed under mild sedation, a fluid is injected underneath the lesion and then a specialized knife is used to dissect the submucosa away. However, performing colorectal ESD is technically demanding since the colorectal wall is thin and constantly moving. Peristalsis can change the access to the lesion site and sharp bends can further limit access. Hence, a minimum of 50-100 cases are necessary to minimize incidence of intra-operative complications (e.g., bleeding and perforations) and attain basic proficiency. It is anticipated that a virtual reality (VR)-based trainer, with visual and haptic (touch) feedback, will be invaluable for training in ESD, allowing trainees to attain competence in a controlled environment with no risk to patients; customized learning; and real time feedback, mentoring and objective assessment. The goal of the present proposal is to design, develop and validate a Virtual Endoluminal Surgical Simulator (VESS) that can be used to train endoscopists in ESD. Such a simulator will have wider use in training of a variety of other submucosal surgical procedures (e.g., peroral endoscopic myotomy, endomicroscopy for the diagnosis of functional and motility disorders and peroral transgastric approaches to the peritoneum and mediastinum) which have been developed with a therapeutic intent other than the resection of tumors. A multidisciplinary team has been assembled to achieve the following Specific Aims: (SA 1) Design and develop a Virtual Endoluminal Surgical Simulator (VESS) platform for advanced therapeutic endoscopic procedures. Specifically, we will develop (1) physics-based computational models of human anatomy based upon in vivo experimental studies; and (2) haptic hardware interface. (SA 2) Develop training scenarios for endoscopic submucosal dissection (ESD) within the VESS with formative and summative performance feedback. Specifically, we will (i) integrate the computational models and in vivo experimental data from SA1 to develop a hands-on skill training environment for ESD which will allow the trainee to perform alternative approaches and encounter consequences of typical pitfalls and (ii) generate a performance feedback module for providing formative and summative feedback to the learner. (SA 3) Establish the validity of the VESS as a training tool by conducting experiments at Beth Israel Deaconess Medical Center with subjects voluntarily enrolled from local Boston medical schools and teaching hospitals to ensure that appropriate skills are being learnt on the VESS and performance measured on the VESS reflect the technical skills they intend to measure.