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: 10078943
• 负责人: Guillermo J Tearney
• 金额: $ 66.33万
• 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 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10078943
• 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; 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).

大多数上消化道疾病的诊断目前是通过上消化道内镜活检来完成的