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NCT Number: NCT06773832

AI in Predicting Polyp Pathology and Endoscopic Classification

Background: Colonoscopy with optical diagnosis based on the appearance of polyps can guide the selection of endoscopic treatment methods, reduce unnecessary polypectomy procedures and the need for tissue pathological diagnosis, and formulate follow-up strategies in a timely manner [1]. This approach significantly alleviates the economic burden on patients and the healthcare system and can effectively ease the tension on clinical resources [2]. Various endoscopic polyp classification methods, including Pit Pattern [3], NICE [4], WASP [5], and MS [6], are used to determine pathological types. However, mastering these classification methods requires endoscopists to undergo extensive training, and due to the inherent flaws in each method, no single endoscopic classification method can accurately diagnose all types of polyps to meet the requirements of optical diagnosis. This limitation has hindered the widespread application of optical diagnosis in clinical practice [7]. The application of artificial intelligence technology in this field, known as computer-aided diagnosis (CADx), has seen rapid development in recent years. Numerous large-scale, prospective studies have demonstrated that the accuracy of CADx technology for optical diagnosis of minute lesions (<5mm) has essentially met the threshold set by European and American endoscopy societies for optical diagnosis [8,9]. However, the diagnostic efficacy of CADx for polyps ≥5mm remains unclear. Moreover, current research is mostly limited to distinguishing between common adenomas and hyperplastic polyps, with little attention given to serrated lesions, which are also precancerous lesions and progress even more rapidly, and are more challenging for endoscopists to assess. These reasons prevent CADx from being widely applied in clinical practice for real-time accurate judgment of polyp pathological types.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

Location status: Recruiting

Location contact

Wenmo Hu, MD

CONTACT

[email protected]

86+15101581963

Wenmo Hu, MD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Outpatients or inpatients undergoing routine colonoscopy screening at the endoscopy centers of multicenter hospitals;
  • Aged 18 years or older;
  • Have understanding of the study content and have signed the informed consent form.

Exclusion criteria

  • Gastroparesis or gastric outlet obstruction;
  • Known or suspected intestinal obstruction or perforation;
  • Severe chronic renal failure (creatinine clearance less than 30 mL/minute);
  • Severe congestive heart failure (New York Heart Association Class III or IV);
  • Currently pregnant or breastfeeding;
  • Toxic colitis or megacolon;
  • Poorly controlled hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg);
  • Moderate or massive active gastrointestinal bleeding (>100 mL/day);
  • Significant psychiatric or psychological illness;
  • Allergy to medications used for bowel preparation;
  • Patients who have undergone colorectal surgery.

Treatment and study plan

Real-time Artificial Intelligence Model for Diagnosing Colorectal Polyp Pathology and Endoscopic Classification

Diagnostic Test

During the AI model development phase, the aim is to include as many samples as possible. Given the focus on the diagnostic accuracy of serrated lesions, we retrospectively collected approximately 400 cases serrated lesions with pathological diagnosis by the department of pathology at Peking Union Medical College Hospital to date. Additionally, we matched with 400 cases each of hyperplastic polyps, conventional adenomas, and early-stage colorectal cancer, totaling approximately 1600 cases.

The model employs mainstream AI classification algorithms to construct the model and compare the predictive performance of different models. Utilizing the dataset established in the first phase, which contains static images of polyp lesions along with their corresponding pathological diagnosis and endoscopic classifications, we developed and optimized the AI model. Then the model will be be compared with endoscopists in a prospective cohort to investigate the efficacy.

Primary outcomes

  1. Accuracy of Optical Diagnosis for Colorectal Polyps

    Time frame: 2 years

    The accuracy of the AI model's optical diagnosis is compared with that of endoscopists, with pathological diagnosis serving as the gold standard.

Secondary outcomes

  1. Other Assessment Parameters of Optical Diagnosis

    Time frame: 2 years

    Including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of Optical Diagnosis

  2. Accuracy in Determining Endoscopic Classification of Colorectal Polyps

    Time frame: 2 years

    Using the endoscopic classification judgment of experienced endoscopists as the gold standard, the study investigates the accuracy of the AI model in determining the endoscopic classification of lesions. The endoscopic classifications include Pit Pattern, CP, NICE, JNET, WASP, and MS.

  3. Other Assessment Parameters in Determining Endoscopic Classification

    Time frame: 2 years

    The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI Model in determining endoscopic classification of colorectal polyps

Study contacts

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

Wenmo Hu, MD

CONTACT

[email protected]

86+15101581963

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Artificial Intelligence Predicts the Pathology and Endoscopic Classification of Colorectal Polyps During Colonoscopy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

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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