Diagnostic Value of Endocytoscopy for Colorectal Lesions

NCT06324097 | Completed

• 1 other identifier: 2024-623
• Study Type: observational
• Target: 463
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (5)

• sensitivity

  April 2024

• specificity

  April 2024

• accuracy

  April 2024

• positive predictive value

  April 2024

• negative predictive value

  April 2024

Secondary Outcomes (2)

• inter-observer agreement

  April 2024

• intra-observer agreement

  April 2024

Study Arms (1)

colorectal lesion

Diagnostic Test: endocytoscopy

Interventions

endocytoscopy DIAGNOSTIC_TEST

The colorectal lesions had been observed with EC-NBI and EC-stained by endoscopists before treatment that were ultimately performed histopathologic examination. The endocytoscopies (CF-H290ECI, Olympus, Tokyo, Japan) have a maximum magnification of ×520, focusing depth, 35 μm; field of view, 570 × 500μm. During EC-NBI , the endoscopist pushed the button of the endoscope to switch from white-light imaging to NBI and observed the lesion with full magnification. Finally, the endoscopist performed EC-stained mode diagnosis after staining the lesion surface with 1.0% methylene blue.

colorectal lesion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The investigators analyzed only endoscopically or surgically resected colorectal lesions (hyperplastic polyps, adenomas and invasive cancers) that had been observed with EC-NBI and EC-stained by endoscopists before treatment that were ultimately performed histopathologic examination.

You may qualify if:

• colorectal lesions

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Xu: lead

Study Sites (1)

the Department of Gastroenterology and Endoscopy Center, First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Post-operative colorectal lesion specimen

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Gastroenterology and Endoscopy Center, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 21, 2024
• Study Start: April 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: February 28, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

CN (1)