A tethered capsule endoscopic-endomicroscopic (TEEM) approach for improving upper GI tract diagnosis

用于改善上消化道诊断的系留胶囊内镜-内镜 (TEEM) 方法

• 批准号: 10327702
• 负责人: Guillermo J Tearney
• 金额: $ 53.44万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10327702
• 关键词: Adoption; Agreement; Algorithms; Area; Back; Barrett Esophagus; Biopsy; Biopsy Specimen; Celiac Disease; Cellular Morphology; Clinical; Conscious Sedation; Correlative Study; Cost Effectiveness Analysis; Data; Deglutition; Devices; Diagnosis; Diagnostic; Digestive System Disorders; Disease; Duodenum; Endoscopic Biopsy; Endoscopy; Engineering; Eosinophilic Esophagitis; Esophageal Adenocarcinoma; Esophagitis; Esophagogastroduodenoscopy; Esophagus; Family; Family suidae; Forcep; Gastrointestinal Diseases; Grant; Health; Health Care Costs; Histology; Histopathology; Human; Human Resources; Image; Imaging Techniques; Intraobserver Variability; Light; Methods; Microscopic; Microscopy; Morbidity - disease rate; Optical Coherence Tomography; Optics; Outpatients; Patient Monitoring; Patients; Peptic Ulcer; Physicians; Procedures; Pylorus; Questionnaires; Reproducibility; Resolution; Risk; Risk Factors; Sampling; Sampling Errors; Scanning; Sedation procedure; Side; Small Intestines; Source; Stomach; System; Techniques; Technology; Testing; Time; Tissue Banks; Tissue Sample; Tissues; Training; Ulcer; Upper digestive tract structure; Work; capsule; cost; cost effective; data streams; design; diagnostic accuracy; diagnostic criteria; gastrointestinal; imaging modality; imaging system; improved; in vivo; microendoscopy; microscopic imaging; mortality; patient tolerability; pill; point of care; screening; standard of care

The diagnosis of most upper GI tract conditions is currently accomplished by upper endoscopy with biopsy (EGD). EGD is costly primarily because it requires conscious sedation, necessitating that procedures be conducted by physicians in a specialized endoscopy suite, and that patients take time away from work and family. Another limitation is sampling error - endoscopic biopsies are frequently random, resulting in many instances of missed disease. Methods such as unsedated transnasal endoscopy (uTNE) have been proposed to decrease the cost of EGD. While in principle uTNE techniques could be used in most cases, physician- associated expense, poor patient acceptance, and an inability to obtain adequate biopsies have hampered its adoption. As a result, there remains an unmet clinical need for an unsedated, less expensive, and more accessible technique that could supersede diagnostic EGD. In this grant, we will develop a replacement for diagnostic EGD that combines video endoscopy with cellular- resolution in vivo microscopy in a swallowable, tethered capsule. Once swallowed, the tethered capsule endoscopy-endomicroscopy (TEEM) device will acquire wide area white light and microscopic images of the esophagus, stomach, and duodenum. Because patients will be unsedated, the procedure can be performed by non-physician personnel in an outpatient setting, thereby improving patient tolerance, increasing efficiency, and lowering costs, resulting in better screening and treatment of this important source of mortality/morbidity. In Aim 1, we will develop the TEEM imaging system and capsule that will incorporate a new cross-sectional, 1-µm- resolution imaging modality known as µOCT, a controllable-stiffness and articulating tether that will facilitate navigation of the stomach, side-viewing white light image acquisition, forward-viewing video, and algorithms for registering µOCT and endoscopy imaging data for offline review. In Aim 2, we will conduct a histopathologic correlative biopsy study to determine the accuracy of µOCT for diagnosing the most common upper GI tract diseases. TEEM tolerance, inter/intra-observer variability, and test-retest reproducibility will then be tested in 55 patients to verify that this technology meets the clinical requirements for upper GI tract screening (Aim 3).

目前，大多数上胃肠道条件的诊断是通过内窥镜检查来完成的 （EGD）。 EGD是代价高昂的主要主要因素，因为它需要有意识的镇静，因此需要进行程序 由医生在专门的内窥镜检查套件中进行的，患者花时间离开工作和 家庭。另一个限制是采样误差 - 内窥镜活检通常是随机的，导致许多 错过疾病的实例。已经提出了诸如未编辑的跨纳萨内窥镜（UTNE）之类的方法 降低EGD的成本。虽然原则上可以在大多数情况下使用UTNE技术，但是 相关的费用，患者的接受度不佳以及无法获得足够的活检已阻碍 采用。结果，对未满足，更便宜和更多的未满足的临床需要 可访问的技术可以取代诊断EGD。 在这笔赠款中，我们将开发诊断EGD的替代品，该诊断EGD将视频内窥镜与细胞 - 在可吞咽的束缚胶囊中的体内显微镜分辨率。一旦吞下，束缚胶囊 内窥镜 - 内镜检查（TEEM）装置将获取广阔的白光和微观图像 食道，胃和十二指肠。因为将解开病人，所以可以通过 在门诊环境中的非医师人员，从而提高患者的容忍度，提高效率和 降低成本，从而更好地筛查和治疗这一重要的死亡率/发病率来源。在 AIM 1，我们将开发TEEM成像系统和胶囊，该系统将结合新的横截面1- µm- 分辨率成像模式称为µoCT，一种控制器 - 状态和明确的系绳，将有助于 摊位的导航，侧面观看白光图像获取，前视频和算法的导航 注册µOCT和内窥镜成像数据以进行离线审查。在AIM 2中，我们将进行组织病理学 相关活检研究以确定最常见的上胃肠道的μoCT准确性 疾病。然后将在55中测试TEEM公差，间/内部观察者的变异性和测试重复可重复性 患者验证该技术是否满足上胃肠道筛查的临床要求（AIM 3）。