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

基本信息

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
项目类别：
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

项目摘要

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，大多数上消化道疾病的诊断是通过上消化道内窥镜检查和活检来完成的 (EGD) 费用昂贵，主要是因为它需要有意识的镇静，因此需要进行手术。由医生在专门的内窥镜套件中进行，患者可以从工作中抽出时间来进行检查另一个限制是采样误差——内窥镜活检通常是随机的，导致许多样本。已经提出了诸如非镇静经鼻内窥镜检查（uTNE）等方法的漏诊实例。虽然原则上 uTNE 技术可以在大多数情况下使用，但医生- 相关费用、患者接受度差以及无法获得足够的活检阻碍了其因此，对于无镇静剂、更便宜且效果更好的药物的临床需求仍然未得到满足。可以取代诊断 EGD 的可用技术。在这笔赠款中，我们将开发一种诊断 EGD 的替代品，将视频内窥镜与细胞- 可吞咽的系留胶囊中的体内显微镜分辨率一旦被吞咽，系留的胶囊就会出现。内窥镜-内窥镜（TEEM）设备将获取大面积白光和显微图像由于患者无需使用镇静剂，因此该手术可以通过以下方式进行：门诊环境中的非医生人员，从而提高患者的耐受性，提高效率，降低成本，从而更好地筛查和治疗这一重要的死亡/发病来源。目标 1，我们将开发 TEEM 成像系统和胶囊，其中将采用新的横截面 1-μm- 称为 µOCT 的分辨率成像模式，一种可控刚度和铰接系绳，将有助于胃导航、侧视白光图像采集、前视视频和算法注册 µOCT 和内窥镜成像数据以供离线审查在目标 2 中，我们将进行组织病理学检查。相关活检研究以确定 µOCT 诊断最常见上消化道的准确性然后将在 55 种疾病中测试 TEEM 耐受性、观察者间/观察者内变异性和重测重现性。患者验证该技术是否满足上消化道筛查的临床要求（目标 3）。