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
基本信息
- 批准号:10383413
- 负责人:
- 金额:$ 25.66万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AdoptionAnastomosis - actionAngiographyAnimalsAreaBlood VesselsBusinessesCancer EtiologyCancerousCessation of lifeChildClinicalClinical ResearchClinical assessmentsCollaborationsColonColon CarcinomaColorColorectalColorectal CancerColorectal SurgeryComplicationContrast MediaDevelopmentDevicesDiagnosisDyesEngineeringEvaluationExcisionExposure toExtravasationFaceFamily suidaeFluorescenceFluorescence AngiographyFluorescent DyesGoalsHealthHemorrhageHospitalsImageImage-Guided SurgeryImaging TechniquesImaging technologyImpairmentIndocyanine GreenInflammatory Bowel DiseasesInjectionsIntestinal DiseasesIntestinesIonizing radiationIschemic Bowel DiseaseLabelLaparoscopesLaparoscopic Surgical ProceduresLaparoscopyLaser Speckle ImagingLeadLegal patentMagnetic Resonance ImagingManualsMesenteryMethodsMicrocirculationModelingMorbidity - disease rateMosaicismMultimodal ImagingNear-infrared optical imagingNecrosisOperating RoomsOperative Surgical ProceduresOpticsOutcomePalpationPatient-Focused OutcomesPatientsPerformancePerfusionPeristalsisPersonal SatisfactionPhasePhysiologic pulsePilot ProjectsPlayPostoperative CarePostoperative PeriodProceduresProcessReportingResearchResearch PersonnelResearch ProposalsResectedRiskSecond Look SurgerySecondary toSmall Business Technology Transfer ResearchStatistical Data InterpretationSurfaceSurgeonSystemTechniquesTechnologyTechnology AssessmentTimeTissue ViabilityTissuesTouch sensationUltrasonographyUnited StatesValidationVascular blood supplyVisionVisualizationWomanX-Ray Computed Tomographybaseclinical translationcolorectal cancer treatmenteffectiveness evaluationexperiencehuman subjectimaging platformimaging systemimprovedin vivo Modelinsightintestine surgerymenminimally invasivemortalitymultimodalitynoveloperationoptical imagingperfusion imagingphase 2 studyporcine modelpre-clinicalpreservationpreventprototypequantitative imagingrapid techniquesoftware developmenttissue oxygenationtool
项目摘要
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。
项目成果
期刊论文数量(0)
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Richard Jaepyeong Cha其他文献
Richard Jaepyeong Cha的其他文献
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{{ truncateString('Richard Jaepyeong Cha', 18)}}的其他基金
A Biliary Tract-Specific Fluorescence Image-guided Surgery
胆道特异性荧光图像引导手术
- 批准号:
10323760 - 财政年份:2021
- 资助金额:
$ 25.66万 - 项目类别:
hANDY-i(TM): A non-invasive, dual-sensor handheld imager for intraoperative preservation of parathyroid glands
hANDY-i(TM):一种非侵入性双传感器手持式成像仪,用于术中保存甲状旁腺
- 批准号:
10545988 - 财政年份:2020
- 资助金额:
$ 25.66万 - 项目类别:
hANDY-i(TM): A non-invasive, dual-sensor handheld imager for intraoperative preservation of parathyroid glands
hANDY-i(TM):一种非侵入性双传感器手持式成像仪,用于术中保存甲状旁腺
- 批准号:
10706615 - 财政年份:2020
- 资助金额:
$ 25.66万 - 项目类别: