Dye-free, multimodal, quantitative imaging to assess bowel perfusion during laparoscopic colorectal resection

无染料、多模态、定量成像，用于评估腹腔镜结直肠切除术期间的肠道灌注

• 批准号: 10383413
• 负责人: Richard Jaepyeong Cha
• 金额: $ 25.66万
• 依托单位: OPTOSURGICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10383413
• 关键词: Adoption; Anastomosis - action; Angiography; Animals; Area; Blood Vessels; Businesses; Cancer Etiology; Cancerous; Cessation of life; Child; Clinical; Clinical Research; Clinical assessments; Collaborations; Colon; Colon Carcinoma; Color; Colorectal; Colorectal Cancer; Colorectal Surgery; Complication; Contrast Media; Development; Devices; Diagnosis; Dyes; Engineering; Evaluation; Excision; Exposure to; Extravasation; Face; Family suidae; Fluorescence; Fluorescence Angiography; Fluorescent Dyes; Goals; Health; Hemorrhage; Hospitals; Image; Image-Guided Surgery; Imaging Techniques; Imaging technology; Impairment; Indocyanine Green; Inflammatory Bowel Diseases; Injections; Intestinal Diseases; Intestines; Ionizing radiation; Ischemic Bowel Disease; Label; Laparoscopes; Laparoscopic Surgical Procedures; Laparoscopy; Laser Speckle Imaging; Lead; Legal patent; Magnetic Resonance Imaging; Manuals; Mesentery; Methods; Microcirculation; Modeling; Morbidity - disease rate; Mosaicism; Multimodal Imaging; Near-infrared optical imaging; Necrosis; Operating Rooms; Operative Surgical Procedures; Optics; Outcome; Palpation; Patient-Focused Outcomes; Patients; Performance; Perfusion; Peristalsis; Personal Satisfaction; Phase; Physiologic pulse; Pilot Projects; Play; Postoperative Care; Postoperative Period; Procedures; Process; Reporting; Research; Research Personnel; Research Proposals; Resected; Risk; Second Look Surgery; Secondary to; Small Business Technology Transfer Research; Statistical Data Interpretation; Surface; Surgeon; System; Techniques; Technology; Technology Assessment; Time; Tissue Viability; Tissues; Touch sensation; Ultrasonography; United States; Validation; Vascular blood supply; Vision; Visualization; Woman; X-Ray Computed Tomography; base; clinical translation; colorectal cancer treatment; effectiveness evaluation; experience; human subject; imaging platform; imaging system; improved; in vivo Model; insight; intestine surgery; men; minimally invasive; mortality; multimodality; novel; operation; optical imaging; perfusion imaging; phase 2 study; porcine model; pre-clinical; preservation; prevent; prototype; quantitative imaging; rapid technique; software development; tissue oxygenation; tool

Anastomotic leak (AL) is a serious complication of intestinal surgery, with many potential causes. This complication carries with it a reported mortality ranging from 6 to 39%. The best time to prevent a possible AL is during its creation in the operating room. A leak can occur due to a technical error, but frequently it occurs as a consequence of poorly vascularized intestine. Creating a healthy and safe intestinal anastomosis requires a good blood supply to the two ends of bowel to be joined. The tools for diagnosing well-perfused bowel intraoperatively are limited and often rely on the subjective evaluation of the surgeon. This is problematic especially in circumstances in which the bowel appears to be "dusky" or threatened but not clearly necrotic. The surgeon can utilize serosal visualization and palpation of the mesenteric vessels, but this fails to evaluate the micro-perfusion of the intestine itself. In addition, most of the research on adoption of laparoscopic techniques in colorectal surgery shows increased rates of use (55.4% of the total of 309,816 patients who underwent elective colon resection between 2009 and 2012 were performed minimally invasively). However, techniques using laparoscopic surgery or minimally invasive surgery (MIS) can be even less reliable for determining bowel viability due to lack of gross palpation. In this research, we propose to develop a dye-free, multimodal laparoscopic imaging system for the quantitative assessment of bowel perfusion for precise surgical guidance during laparoscopic (and open) intestinal surgery. Optosurgical, LLC is a small business that has established a strong partnership with researchers at Children's National Hospital, where expert clinicians and engineers will provide requisite clinical insight on the full development, preclinical validation, and clinical translation of the proposed technology from the bench to the operating room. The goal of this 1-year research proposal is to develop and evaluate the novel multimodal imaging camera system for laparoscopic anastomosis through the following specific aims; Aim 1: To prototype the multimodal camera system and integrate the system into a commercially available laparoscope; Aim 2: To validate the system pre-clinically in a swine model of in vivo intestinal ischemia (n=12). Upon successful completion of this STTR Phase 1 project, we will proceed with the Phase 2 studies, wherein we will prepare a clinical grade device and execute animal studies using a swine model with statistical validation, followed by a pilot clinical study on human subjects. This new optical imaging technology holds great promise for evaluating bowel perfusion and potential intrinsic intestinal disorders with the goal of reducing postoperative morbidity/mortality and second-look operations for suspected intestinal leaks.

吻合口瘘（AL）是肠道手术的严重并发症，其潜在原因有很多。 据报道，这种并发症的死亡率为 6% 至 39%。最好的时间 在手术室创建过程中防止可能发生的 AL。泄漏可能是由于 技术错误，但它经常是由于肠道血管化不良而发生的。 创建健康安全的肠道吻合口需要良好的两端血液供应 肠要加入。术中诊断灌注良好的肠道的工具有限 并且常常依赖于外科医生的主观评价。这是有问题的，尤其是在 肠道看起来“暗淡”或受到威胁但没有明显坏死的情况。这 外科医生可以利用浆膜可视化和肠系膜血管触诊，但这失败了 评估肠道本身的微灌注。此外，大部分研究都是关于 结直肠手术中腹腔镜技术的采用表明使用率有所增加（55.4% 2009年至2012年间，共有309,816名患者接受了选择性结肠切除术 均以微创方式进行）。然而，使用腹腔镜手术或 微创手术（MIS）对于确定肠道活力的可靠性甚至更低 由于缺乏肉眼触诊。 在这项研究中，我们建议开发一种无染料、多模态腹腔镜成像系统 定量评估肠道灌注，以在术中精确指导手术 腹腔镜（和开腹）肠道手术。 Optosurgical, LLC 是一家小型企业， 与国家儿童医院的研究人员建立了牢固的合作伙伴关系， 专家临床医生和工程师将提供必要的临床见解 所提议技术的全面开发、临床前验证和临床转化 从工作台到手术室。 这项为期一年的研究计划的目标是开发和评估新型多模态成像 用于腹腔镜吻合术的摄像系统通过以下具体目标；目标 1：原型 多模态相机系统并将该系统集成到商用 腹腔镜；目标 2：在猪体内肠道模型中对该系统进行临床前验证 缺血（n=12）。 成功完成 STTR 第一阶段项目后，我们将继续进行第二阶段研究， 其中我们将准备一个临床级设备并使用猪模型进行动物研究 统计验证，然后对人类受试者进行试点临床研究。这种新型光学 成像技术在评估肠道灌注和潜在内在特性方面具有广阔的前景 肠道疾病，旨在降低术后发病率/死亡率和复查 疑似肠漏的手术。