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Clinical Trials/NCT06324097
NCT06324097
Completed
Not Applicable

Diagnostic Value of Two Different Mode Endocytoscopy for Colorectal Lesions

Hong Xu1 site in 1 country463 target enrollmentApril 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Neoplasms
Sponsor
Hong Xu
Enrollment
463
Locations
1
Primary Endpoint
accuracy
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

Colorectal cancer (CRC) is the third most common malignancy and the second leading cause of cancer-related death worldwide. Colonoscopy is considered the preferred method of screening for colorectal cancer, and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer. In order to improve the qualitative and quantitative diagnosis of colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy (IEE), including narrowband imaging (NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy (EC) are applied clinically. The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy. Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC. Based on the endoscopic diagnosis, the endoscopist can determine the treatment plan for the colorectal lesions. The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x. EC may demonstrate the atypical of gland structure and cells after staining (EC staining mode, along with the use of the EC-NBI mode. The endoscopic diagnosis of the EC staining mode is based on the EC classification (EC-C), used to predict the histopathological diagnosis of colorectal lesions. A prospective randomized trial showed that the diagnostic accuracy was 94.1% by EC-C. However, the diagnostic value of EC-C depends on the operator and may be influenced by the quality of the staining. Meanwhile, the high-quality staining process is time-consuming and tedious. Therefore, EC-NBI seems to be the first choice for EC diagnosis with the advantages of convenient operation and efficient diagnosis. EC-NBI can display the super-amplified surface microvessels of the lesion and provide pathological prediction according to the vessel classification (EC-V). EC-V achieved 99% diagnostic accuracy for hyperplastic polyps and 88.6% for invasive carcinoma. In EC examination, the investigators usually use EC-NBI and EC staining successively to diagnose colorectal lesions, which is believed to improve the diagnostic performance. However, the diagnostic value of increasing EC-staining after EC-NBI examination for predicting the pathological nature of colorectal lesions is still unclear. Therefore, this retrospective study aimed to evaluate the diagnostic value of two different modalities of cell endoscopy for colorectal lesions and to clarify whether additional EC staining after EC-NBI could improve the diagnostic performance of predicting the pathological diagnosis of colorectal lesions.

In the study, the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis (including EC-NBI and EC-staining) and pathological diagnosis. Then, the investigators calculate the accuracy, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and high confidence diagnosis rate of EC-C and EC-V classification, respectively. Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated.

Registry
clinicaltrials.gov
Start Date
April 1, 2024
End Date
February 28, 2025
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Hong Xu
Responsible Party
Sponsor Investigator
Principal Investigator

Hong Xu

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

The First Hospital of Jilin University

Eligibility Criteria

Inclusion Criteria

  • colorectal lesions

Exclusion Criteria

  • non-epithelial tumors
  • sessile serrated lesions
  • inflammatory polyps
  • juvenile polyps
  • hamartomatous polyps
  • a history of inflammatory bowel disease
  • chemotherapy or radiation therapy for colorectal cancer
  • lesions without clear EC images.

Outcomes

Primary Outcomes

accuracy

Time Frame: April 2024

sensitivity

Time Frame: April 2024

negative predictive value

Time Frame: April 2024

specificity

Time Frame: April 2024

positive predictive value

Time Frame: April 2024

Secondary Outcomes

  • inter-observer agreement(April 2024)
  • intra-observer agreement(April 2024)

Study Sites (1)

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