跳至主要内容
临床试验/NCT06399120
NCT06399120招募中不适用

Diagnostic Performance of Endocytoscopy for Colorectal Lesions

The First Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
1
主要终点
specificity of diagnosing colorectal lesions using endocytoscopy

研究概览

简要总结

Colorectal cancer is the third most common malignancy worldwide and the second leading cause of cancer-related death. About 70% of colorectal cancers develop through the adenoma-cancer pathway. Early detection and resection of colorectal neoplastic lesions significantly reduce the morbidity and mortality of colorectal cancers. Colonoscopy is considered to be the preferred method for screening for colorectal lesions. However, as the number of endoscopic resection increases, the costs associated with pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, it will be very important and urgent to correctly judge the nature of colorectal lesions to avoid pathological diagnosis and then realize optical biopsy. Therefore, to clarify the endoscopic diagnosis of colorectal lesions, many endoscopic techniques have been applied clinically. Such as narrow-band imaging, magnifying narrow-band imaging endoscopy, magnifying chromoendoscopy and endocytoscopy. Endocytoscopy has two modes, EC-NBI mode and EC-staining mode. EC-NBI mode is to observe the microvessel on the mucosal surface of colorectal mucosa after switching the endoscopy to NBI mode. EC-V pattern is used to observe microvessels and then endoscopic diagnosis is performed. The EC-staining mode was that the cell nuclei and glandular duct morphology of colorectal lesions could be observed by endocytoscopy after chemical staining. Endocytoscopic diagnosis is performed clinically after observation of glandular ducts and nuclei. However, current studies on the diagnostic value of endoscopy in colorectal lesions are all retrospective studies with small samples, and there is a lack of clinical studies based on chinese population. Therefore, our center intends to conduct a study of a large sample to explore the diagnostic value of endoscopy in colorectal lesions.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • colorectal lesions

排除标准

  • non-epithelial tumors
  • a history of inflammatory bowel disease
  • lesions without clear EC images
  • specific pathological types
  • familial adenomatous polyposis

结局指标

主要结局

specificity of diagnosing colorectal lesions using endocytoscopy

时间窗: May 2025

The percentage of patients with non-specific types of colorectal disease who received a negative result using endocytoscopy.

negative predictive value of diagnosing colorectal lesions using endocytoscopy

时间窗: May 2025

The percentage of non-patients with negative results when using endocytoscopy to diagnose colorectal lesions.

sensitivity of diagnosing colorectal lesions using endocytoscopy

时间窗: May 2025

The percentage of patients with a specific type of colorectal disease who received a positive result by endocytoscopy.

accuracy of diagnosing colorectal lesions using endocytoscopy

时间窗: May 2025

The percentage of correct results that is obtained by endocytoscopy.

positive predictive value of diagnosing colorectal lesions using endocytoscopy

时间窗: May 2025

The percentage of patients with positive results when using endocytoscopy to diagnose colorectal lesions.

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

Hong Xu

Director, Head of Gastroenterology and Endoscopy Center, Principal Investigator, Clinical Professor

The First Hospital of Jilin University

研究点 (1)

Loading locations...

相似试验