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.

用于治疗以下疾病的虚拟腔内手术模拟器 (VESS) 的开发和验证 结直肠癌 抽象的 结直肠癌 (CRC) 是美国男性和女性第三大常见癌症 癌症相关死亡的第二大原因。但早期诊断、早期治疗是关键 提高生存率。在美国，采用内窥镜检查的非常积极的筛查计划已到位，以减少结直肠癌。 随着介入内窥镜技术的进步，切除结直肠息肉和切除结直肠息肉的趋势日益明显。 使用通过工作通道推进的小型灵活工具进行内窥镜治疗早期结直肠癌 内窥镜。内窥镜治疗是一种微创治疗，具有一定的优势，包括更快 与传统方法相比，康复快、住院时间短、费用低、术后生活质量更好 肠道手术。使用勒除器的传统息肉切除术对于有蒂肿瘤（细长的肿瘤）效果很好。 有柄肿瘤），但对于无蒂或扁平肿瘤则不然，不幸的是，它们具有更高的风险 癌症。针对此类肿瘤，已经开发了内窥镜粘膜切除（EMR）技术。 然而，对于大肿瘤（>2cm），EMR 存在并发症和完全清除（整体）的风险 切除术）可能无法实现，导致复发和残留肿瘤的风险很高。内窥镜 粘膜下剥离术 (ESD) 是一种允许完全整块切除并可能治愈的技术 肿瘤不受大小限制，从而实现精确的组织病理学切缘和更低的复发率 在长期随访中。这项技术可以在轻度镇静的情况下进行，注射液体 然后使用专门的刀将粘膜下层切开。然而， 由于结直肠壁薄且不断移动，因此进行结直肠 ESD 技术要求很高。 蠕动可以改变到达病变部位的通道，而急弯可以进一步限制通道。因此，一个 至少需要 50-100 例，以尽量减少术中并发症（例如出血）的发生率 和穿孔）并达到基本熟练程度。 预计将有一个基于虚拟现实 (VR) 的训练器，具有视觉和触觉（触摸）反馈。 对于 ESD 培训来说非常有价值，使学员能够在受控环境中无风险地获得能力 对患者；定制化学习；以及实时反馈、指导和客观评估。目标是 目前的建议是设计、开发和验证虚拟腔内手术模拟器 (VESS) 可用于培训内窥镜医师 ESD。这种模拟器将在训练中具有更广泛的用途 各种其他粘膜下外科手术（例如，经口内窥镜肌切开术、内窥镜检查） 功能和运动障碍的诊断以及经口经胃腹膜的方法和 纵隔），其开发目的是为了除肿瘤切除之外的治疗目的。一个 组建了多学科团队来实现以下具体目标：（SA 1）设计和 开发用于高级治疗的虚拟腔内手术模拟器 (VESS) 平台 内窥镜手术。具体来说，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； (2)触觉硬件接口。 (SA 2) 开展培训 VESS 内内窥镜粘膜下剥离术 (ESD) 的场景，具有形成性和终结性 绩效反馈。具体来说，我们将（i）整合计算模型和体内实验 SA1 的数据用于开发 ESD 实践技能培训环境，使受训者能够执行 替代方法并遇到典型陷阱的后果，并且 (ii) 产生绩效 反馈模块，用于向学习者提供形成性和总结性反馈。 (SA 3) 确定有效性 通过在贝斯以色列女执事医疗中心进行实验，将 VESS 作为培训工具 受试者从波士顿当地医学院和教学医院自愿注册，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水平 他们打算衡量的技能。