RecruitingNCT06791395

Real-time AI-assisted Endocyroscopy for the Diagnosis of Colorectal Lesions

Real-time AI-assisted Endocytoscopy for the Diagnosis of Colorectal Lesions: a Multi-center, Prospective Clinical Study


Sponsor

The First Hospital of Jilin University

Enrollment

508 participants

Start Date

Feb 5, 2025

Study Type

OBSERVATIONAL

Conditions

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 early and resection detection of colorectal neoplastic lesions can significantly reduce colorectal cancer morbidity and mortality. In order to improve the diagnostic accuracy of endoscopy for colorectal lesions, many endoscopic techniques, such as image-enhanced endoscopy, including narrow band imaging (narrow-band imaging, NBI), magnifying endoscopy, pigment endoscopy, confocal laser endoscopy, and endocytoscopy(EC), are applied clinically. However, with the increasing number of endoscopic resection, the costs associated with the pathological diagnosis of endoscopic resection and resection specimens increase year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to identify the nature of the lesion during colonoscopy. Endocytoscopy is a kind of ultra-high magnification endoscopy. Combined with chemical staining and narrow band imaging technology, endoscopists can observe the cell nucleus morphology, gland tube morphology and microvascular morphology with the naked eye, so as to avoid pathological examination and realize the purpose of real-time biopsy in the body. However, the judgment of endocytoscopic images needs a lot of experience to improve the judgment accuracy. Moreover, endoscopists have certain subjective judgments and errors in the process of judging the results. Therefore, artificial intelligence (AI) is proposed for computer-assisted diagnosis in clinic to solve this problem. In the early stage, our center has developed an AI-assisted diagnostic system based on cellular endoscopy to assist the nature of colorectal lesions, but there is still a lack of prospective clinical study to verify the effectiveness of the AI-assisted system. Therefore, the investigatorr want to carry out this clinical study to verify the clinical effectiveness of the AI.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is testing an artificial intelligence (AI) system that helps doctors examine colon and rectal polyps more accurately during a special high-magnification colonoscopy procedure called endocytoscopy. The AI provides real-time assistance in identifying whether growths in the colon are cancerous, pre-cancerous, or benign, potentially reducing the need for unnecessary biopsies. **You may be eligible if...** - You have colorectal lesions (growths in the colon or rectum) that need evaluation during a colonoscopy **You may NOT be eligible if...** - Your lesions do not produce clear, high-quality images during the procedure - You have inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or familial adenomatous polyposis - You have submucosal tumors (growths beneath the inner lining of the colon) - Your lesions are of specific types such as inflammatory polyps, Peutz-Jeghers polyps, juvenile polyps, or lymphoma Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTArtificial intelligence platform for endocytoscopy

The detected lesions are predicted by artificial intelligence


Locations(1)

The First Hospital of Jilin University

Changchun, Jilin, China

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NCT06791395


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