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Diagnostic Performance of Endocytoscopy for Colorectal Lesions

Diagnostic Performance of Endocytoscopy for Colorectal Lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06399120
Enrollment
800
Registered
2024-05-03
Start date
2024-05-01
Completion date
2025-05-31
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Lesions

Keywords

endocytoscopy

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.

Interventions

None listed

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
sensitivity of diagnosing colorectal lesions using endocytoscopyMay 2025The percentage of patients with a specific type of colorectal disease who received a positive result by endocytoscopy.
specificity of diagnosing colorectal lesions using endocytoscopyMay 2025The percentage of patients with non-specific types of colorectal disease who received a negative result using endocytoscopy.
accuracy of diagnosing colorectal lesions using endocytoscopyMay 2025The percentage of correct results that is obtained by endocytoscopy.
positive predictive value of diagnosing colorectal lesions using endocytoscopyMay 2025The percentage of patients with positive results when using endocytoscopy to diagnose colorectal lesions.
negative predictive value of diagnosing colorectal lesions using endocytoscopyMay 2025The percentage of non-patients with negative results when using endocytoscopy to diagnose colorectal lesions.

Countries

China

Contacts

Primary ContactMingqing Liu, Doctor
liumq23@mails.jlu.edu.cn+8613204300453

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026