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NCT Number: NCT06982872

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location status: Recruiting

Location contact

Mingqing Liu

CONTACT

[email protected]

+8613204300453

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

artificial intelligence

Diagnostic Test

Different AI assisted diagnostic systems are used to diagnose lesions.

Primary outcomes

  1. the sensitivity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms

    Time frame: 2025-12-31

    of the intracellular AI platform for diagnosing colorectal neoplastic lesions was not inferior to that of EndoBRAIN.

Secondary outcomes

  1. the accuracy of two AI assisted diagnostic systems for diagnosing colorectal neoplasms

    Time frame: 2025-12-31

  2. specificity of two AI assisted diagnostic systems for diagnosing colorectal neoplasms

    Time frame: 2025-12-31

  3. positive predictive value of two AI assisted diagnostic systems for diagnosing colorectal neoplasms

    Time frame: 2025-12-31

  4. negative predictive value of two AI assisted diagnostic systems for diagnosing colorectal neoplasms

    Time frame: 2025-12-31

  5. the accuracy of two AI assisted diagnostic systems for diagnosing colorectal invasive cancer

    Time frame: 2025-12-31

  6. The accuracy of two AI assisted diagnostic systems in diagnosing lesions of the rectoileal colon ≤5 mm

    Time frame: 2025-12-31

  7. the high confidence diagnosis rate of two AI assisted diagnostic systems for diagnosing colorectal lesions

    Time frame: 2025-12-31

  8. the diagnostic time of two artificial intelligence assisted diagnosis systems

    Time frame: 2025-12-31

Study contacts

Contact information is provided by the study sponsor or research team.

Mingqing Liu, Doctor

CONTACT

[email protected]

15043076005

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
May 25, 2025

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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