Diagnostic Performance of Endocytoscopy for Colorectal Lesions

NCT ID: NCT06399120

Last Updated: 2024-05-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-05-31

Brief 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.

Conditions

Colorectal Lesions

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Hong Xu

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mingqing Liu

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mingqing Liu, Doctor

Role: CONTACT

liumq23@mails.jlu.edu.cn

+8613204300453

Facility Contacts

Mingqing Liu

Role: primary

liumq23@mails.jlu.edu.cn

+8613204300453

Other Identifiers

24K102-001

Identifier Type: -

Identifier Source: org_study_id