Diagnostic Performance of Endocytoscopy for Colorectal Lesions

Colorectal Lesions Clinical Trial

Official title:

Diagnostic Performance of Endocytoscopy for Colorectal Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06399120
• Other study ID #: 24K102-001
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: The First Hospital of Jilin University
• Contact: Mingqing Liu, Doctor
• Phone: +8613204300453
• Email: liumq23[@]mails.jlu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• colorectal lesions

Exclusion Criteria:

• non-epithelial tumors

• a history of inflammatory bowel disease

• lesions without clear EC images

• specific pathological types

• familial adenomatous polyposis

Related Conditions & MeSH terms

• Colorectal Lesions

Locations

Country	Name	City	State
China	Mingqing Liu	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensitivity of diagnosing colorectal lesions using endocytoscopy	The percentage of patients with a specific type of colorectal disease who received a positive result by endocytoscopy.	May 2025
Primary	specificity of diagnosing colorectal lesions using endocytoscopy	The percentage of patients with non-specific types of colorectal disease who received a negative result using endocytoscopy.	May 2025
Primary	accuracy of diagnosing colorectal lesions using endocytoscopy	The percentage of correct results that is obtained by endocytoscopy.	May 2025
Primary	positive predictive value of diagnosing colorectal lesions using endocytoscopy	The percentage of patients with positive results when using endocytoscopy to diagnose colorectal lesions.	May 2025
Primary	negative predictive value of diagnosing colorectal lesions using endocytoscopy	The percentage of non-patients with negative results when using endocytoscopy to diagnose colorectal lesions.	May 2025