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

用于治疗结直肠癌的虚拟腔内手术模拟器 (VESS) 的开发和验证

• 批准号: 9535243
• 负责人: Suvranu De
• 金额: $ 40.84万
• 依托单位: RENSSELAER POLYTECHNIC INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-25 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9535243
• 关键词: Active Learning; Anatomy; Animals; Boston; Cadaver; Cancer Etiology; Cessation of life; Colectomy; Colon; Colon Carcinoma; Colonoscopes; Colonoscopy; Colorectal; Colorectal Cancer; Colorectal Neoplasms; Colorectal Polyp; Competence; Computer Simulation; Computers; Controlled Environment; Custom; Data; Development; Diagnosis; Diagnostic; Disease; Dissection; Early Diagnosis; Early treatment; Electrosurgery; Endoscopes; Endoscopy; Enrollment; Ensure; Environment; Evaluation; Excision; Feedback; Fibrosis; Functional disorder; Gastroenterologist; Goals; Healthcare; Hemorrhage; High-Risk Cancer; Incidence; Injections; Instruction; Interdisciplinary Study; Intervention; Intestines; Israel; Lead; Learning; Length of Stay; Lesion; Lifting; Liquid substance; Malignant Neoplasms; Measures; Mediastinum; Medical center; Mentors; Modeling; Morbidity - disease rate; Mucous Membrane; Operative Surgical Procedures; Organ; Patient-Focused Outcomes; Patients; Perforation; Performance; Peristalsis; Peritoneum; Physics; Physiological; Polypectomy; Postoperative Period; Procedures; Quality of life; Reaction; Recovery; Rectum; Recurrence; Research; Research Project Grants; Residual Tumors; Resources; Risk; Sedation procedure; Site; Submucosa; Teaching Hospitals; Technical Expertise; Techniques; Technology; Therapeutic; Thinness; Time; Tissues; Touch sensation; Training; Translating; Treatment Cost; Ulcer; United States; Validation; Visual; Woman; Work; base; cell motility; cognitive skill; colorectal cancer treatment; cost; design; experimental study; eye hand coordination; flexibility; haptics; healing; high risk; human model; improved; in vivo; innovation; lymph nodes; medical schools; men; microendoscopy; minimally invasive; motility disorder; motor control; multidisciplinary; novel; screening; screening program; simulation; skills; skills training; tool; trend; tumor; virtual; virtual reality

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.

虚拟腔内手术模拟器（VESS）的开发和验证 结直肠癌 摘要 结直肠癌（CRC）是美国男性和女性的第三大常见癌症， 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， 提高生存率。在美国，一个非常积极的筛查计划，使用内窥镜检查是在适当的CRC减少。 随着内镜介入技术的进步，切除大肠息肉， 早期结直肠癌内镜下使用小的灵活工具推进通过工作通道的 内窥镜内窥镜治疗是微创的，具有某些优点，包括更快， 与传统手术相比， 肠道手术使用圈套器的传统息肉切除术对于有蒂肿瘤（细长）效果良好 有柄的肿瘤），但对于无柄或扁平肿瘤则不太多，不幸的是， 癌对于这样的肿瘤，已经开发了内窥镜粘膜切除术（EMR）技术。 然而，对于大肿瘤（>2cm），EMR具有并发症和完全清除（整块）的风险 切除）可能无法实现，导致高风险的复发和残留肿瘤。内镜 粘膜下剥离术（ESD）是一种允许完全整块切除并可能治愈 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 在长期随访中。在这种技术中，可以在轻度镇静下进行， 然后用一把专门的刀把粘膜下层切开。然而，在这方面， 进行结肠直肠ESD在技术上要求很高，因为结肠直肠壁很薄并且不断移动。 蠕动可改变病变部位的入路，急弯可进一步限制入路。于是，一 最少需要50-100个病例以最小化术中并发症的发生率（例如，出血 和穿孔），并达到基本的熟练程度。 据预计，一个基于虚拟现实（VR）的教练，与视觉和触觉（触摸）反馈，将 对于可持续发展教育培训非常宝贵，使学员能够在没有风险的受控环境中获得能力 对患者的指导;定制学习;以及真实的时间反馈、指导和客观评估。的目标 本提案是设计、开发和验证虚拟腔内手术模拟器 （VESS），可用于培训内窥镜医生ESD。这种模拟器将在训练 各种其它粘膜下外科手术（例如，经口内镜肌切开术，显微内镜， 功能和运动障碍的诊断以及经口经胃腹膜入路， 纵隔），其已经被开发用于除肿瘤切除之外的治疗目的。一 多学科团队已经组建，以实现以下具体目标：（SA 1）设计和 开发虚拟腔内手术模拟器（VESS）平台，用于先进的治疗 内窥镜手术。具体而言，我们将开发（1）基于物理的人类计算模型 基于体内实验研究的解剖学;和（2）触觉硬件接口。(SA 2）开展培训 在VESS内进行内镜下粘膜下剥离术（ESD）的情景， 绩效反馈具体而言，我们将（i）整合计算模型和体内实验 从SA 1中获取数据，为ESD开发一个实践技能培训环境，使学员能够执行 替代方法和遇到典型陷阱的后果，以及（ii）产生性能 反馈模块，用于向学习者提供形成性和总结性反馈。(SA（3）建立有效性 通过在贝斯以色列女执事医疗中心进行实验， 受试者自愿从波士顿当地医学院和教学医院入组，以确保 在VESS上学习适当的技能，在VESS上测量的性能反映了技术 他们想要衡量的技能。