Diagnostic Performance of Endocytoscopy for Colorectal Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Lesions

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Mingqing Liu, Doctor; Phone Number: +8613204300453; Email: liumq23@mails.jlu.edu.cn

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Recruiting
      • Mingqing Liu
      • Contact: Mingqing Liu; Phone Number: +8613204300453; Email: liumq23@mails.jlu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The investigators analyzed only endoscopically or surgically resected colorectal lesions that had been observed and diagnosed with endoscopic methods by endoscopists that were ultimately performed histopathologic examination.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
accuracy of diagnosing colorectal lesions using endocytoscopy	The percentage of correct results that is obtained by endocytoscopy.	May 2025
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
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

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: April 29, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: endocytoscopy
• Other Study ID Numbers: 24K102-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No