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.

吻合口漏是肠道手术的一种严重并发症，其原因有很多。 据报道，这种并发症的死亡率为6%至39%。的最佳时间 防止在手术室中创建可能的AL。泄漏可能是由于 这是一个技术错误，但它经常发生的结果，不良血管化的肠道。 建立一个健康安全的肠吻合需要良好的血液供应的两端， 肠被加入。术中诊断肠灌注良好的工具有限 并且通常依赖于外科医生的主观评价。这是有问题的，尤其是在 肠道似乎“暗淡”或受到威胁但没有明显坏死的情况。的 外科医生可以利用肠系膜血管的serviewing可视化和触诊，但这失败了 来评估肠道本身的微灌注此外，大多数关于 在结直肠手术中采用腹腔镜技术显示使用率增加（55.4%的 2009年至2012年间，共有309，816名患者接受了选择性结肠切除术， 进行微创手术）。然而，使用腹腔镜手术或 微创手术（MIS）在确定肠存活能力方面甚至更不可靠 因为没有触诊 在这项研究中，我们建议开发一种无染料的多模式腹腔镜成像系统，用于 定量评估肠灌注，用于精确的手术指导， 腹腔镜（和开腹）肠道手术。Optosurgical，LLC是一家小型企业， 与国立儿童医院的研究人员建立了牢固的伙伴关系， 专家临床医生和工程师将提供必要的临床见解， 完整开发、临床前验证和拟议技术的临床转化 从手术台到手术室 这项为期1年的研究计划的目标是开发和评估新型多模态成像 通过以下特定目标实现腹腔镜吻合术的摄像系统;目标1：原型制作 多模式摄像机系统，并将该系统集成到市售的 腹腔镜;目的2：在猪体内肠道模型中对系统进行临床前验证 缺血组12例。 在成功完成这项短期信托基金第一阶段的研究后，我们会继续进行第二阶段的研究， 其中我们将制备临床级装置并使用猪模型进行动物研究， 统计学验证，然后是对人类受试者的试点临床研究。新光学 成像技术在评价肠灌注和潜在的内在 肠道疾病，目的是降低术后发病率/死亡率和二次检查 疑似肠漏的手术。