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临床试验/NCT06984055
NCT06984055Enrolling By Invitation不适用

Diagnostic Accuracy of Deep Learning-Assisted Multimodal Endocytoscopy for Superficial Esophageal Neoplasia and Precancerous Lesions: A Multicenter ,Prospective Study

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2025年3月11日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
600
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

In recent years, endocytoscopy (EC) has undergone rapid development as an advanced endoscopic technique. Characterized by real-time histological imaging and detection capabilities, EC enables visualization of living cells in the digestive mucosal layer through methylene blue staining via the endoscopic instrument channel. This technology provides ultra-magnified endocytoscopic images, allowing for identification of key cellular features including epithelial cell morphology and the shape of methylene blue-stained epithelial nuclei, thereby facilitating clear in vivo observation of microstructural characteristics in mucosal tissues - a technique commonly referred to as "optical biopsy". However, current clinical application of EC in China remains limited due to insufficient practical experience and the absence of standardized diagnostic criteria for image interpretation. This study aims to comprehensively evaluate the diagnostic accuracy of domestically developed high-magnification electronic upper gastrointestinal endoscopy for esophageal carcinoma and precancerous lesions, using histopathology as the gold standard. The research objectives include establishing standardized diagnostic evaluation protocols and clarifying the clinical value of this technology through systematic validation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1.Patients diagnosed with superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) through endoscopic and pathological biopsy examinations, scheduled for endoscopic submucosal dissection (ESD); 2.Patients with esophageal squamous low-grade intraepithelial neoplasia (LGIN) confirmed by endoscopic and biopsy histopathological examinations within the preceding six months;
  • Patients exhibiting esophageal focal lesions detected during painless upper gastrointestinal endoscopy requiring pathological biopsy.

排除标准

  • Patients aged <18 years or >80 years;
  • Lesions located at the gastroesophageal junction with clinical suspicion of adenocarcinoma or precancerous lesions;
  • Patients with contraindications to sedated/anesthetized upper gastrointestinal endoscopy;
  • Patients with coagulation disorders;
  • Patients with a history of hypersensitivity to relevant medications (including anesthetics or methylene blue);
  • Patients presenting dysphagia or gastrointestinal obstructive symptoms, or those with suspected/confirmed digestive tract obstruction, stenosis, or fistulae;
  • Patients declining to provide informed consent for study participation, or any other circumstances deemed by investigators to preclude eligibility.

结局指标

主要结局

Diagnostic accuracy

时间窗: 10 minutes

sensitivity and specificity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luowei Wang, MD

Clinical Professor

Changhai Hospital

研究点 (1)

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