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Comparison of the Diagnostic Performance of Different Artificial Intelligence Assisted Endocytoscopy for Colorectal Lesions

Comparison of the Diagnostic Performance of Different Artificial Intelligence Assisted Endocytoscopy for Colorectal Lesions

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06982872
Enrollment
500
Registered
2025-05-21
Start date
2025-05-21
Completion date
2025-12-31
Last updated
2025-05-25

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

Conditions

Endocytoscopy

Keywords

endocytoscopy, artificial intelligence

Brief summary

Colorectal cancer (colorectal cancer, CRC) is the third most common malignant tumor globally and the second leading cause of cancer-related deaths. Colonoscopy is considered the preferred method for screening colorectal cancer; early detection and removal of colorectal neoplasms can significantly reduce the incidence and mortality of colorectal cancer. To improve the diagnostic accuracy of endoscopy in colorectal lesions, many endoscopic techniques have been applied clinically, such as image-enhanced endoscopy, including narrow band imaging (narrow-band imaging, NBI), magnifying endoscopy, chromoendoscopy, confocal laser endoscopy, and endocytoscopy (EC). However, with the increasing number of endoscopic resections, the costs associated with the pathological diagnosis of resected specimens have risen year by year. In clinical practice, some non-neoplastic colorectal lesions may not require resection, so it is important to differentiate the nature of lesions during colonoscopy. Endocytoscopy is an ultra-high magnification endoscope that, when combined with chemical staining and narrowband imaging techniques, allows endoscopists to observe the nuclear morphology of colorectal lesions, the shape of glands, and the morphology of microvessels with the naked eye, thus avoiding pathological examination and achieving the goal of real-time biopsy in vivo. However, the accuracy of endocytoscopy images requires extensive experience accumulation to improve judgment, and there is a certain degree of subjectivity and error in the process of endoscopists making judgments. Therefore, to address this issue, clinical applications have proposed using artificial intelligence (AI) for computer-aided diagnosis. Currently, Japan has developed an endoscopic cytology auxiliary diagnostic system-EndoBRAIN, based on the Japanese population, which uses support vector machines to build model. The investigator's center has developed a deep learning-based endoscopic cytology AI auxiliary diagnostic system for Chinese populations to assist in determining the nature of colorectal lesions. There is currently a lack of comparative studies on the diagnostic performance of these two systems, so the investigator aim to conduct a clinical study to compare and analyze the differences between the two AI auxiliary diagnostic systems.

Interventions

DIAGNOSTIC_TESTartificial intelligence

Different AI assisted diagnostic systems are used to diagnose lesions.

Sponsors

The First Hospital of Jilin University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

Inclusion criteria

* colorectal lesions

Exclusion criteria

* lesions lacking high-quality images; * Inflammatory bowel disease, familial adenomatous polyposis and other special diseases; * submucosal tumors; * Pathological diagnosis of Peutz-Jeghers polyps, juvenile polyps, lymphoma and other pathological types.

Design outcomes

Primary

MeasureTime frameDescription
the sensitivity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms2025-12-31of the intracellular AI platform for diagnosing colorectal neoplastic lesions was not inferior to that of EndoBRAIN.

Secondary

MeasureTime frame
specificity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms2025-12-31
positive predictive value of two AI assisted diagnostic systems for diagnosing colorectal neoplasms2025-12-31
negative predictive value of two AI assisted diagnostic systems for diagnosing colorectal neoplasms2025-12-31
the accuracy of two AI assisted diagnostic systems for diagnosing colorectal neoplasms2025-12-31
The accuracy of two AI assisted diagnostic systems in diagnosing lesions of the rectoileal colon ≤5 mm2025-12-31
the high confidence diagnosis rate of two AI assisted diagnostic systems for diagnosing colorectal lesions2025-12-31
the diagnostic time of two artificial intelligence assisted diagnosis systems2025-12-31
the accuracy of two AI assisted diagnostic systems for diagnosing colorectal invasive cancer2025-12-31

Countries

China

Contacts

Primary ContactMingqing Liu, Doctor
liumq23@mails.jlu.edu.cn15043076005

Outcome results

None listed

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