About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial population
Patients aged 18 years or older undergoing routine colonoscopy screening
Trial design
Cohort
Prospective
Treatments tested in this trial
Real-time Artificial Intelligence Model for Diagnosing Colorectal Polyp Pathology and Endoscopic Classification
Diagnostic testDuring 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.
Treatment groups
Trial outcomes
Primary outcomes
Accuracy of Optical Diagnosis for Colorectal Polyps
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
Other Assessment Parameters of Optical Diagnosis
Including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of Optical Diagnosis
Accuracy in Determining Endoscopic Classification of Colorectal Polyps
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.
Other Assessment Parameters in Determining Endoscopic Classification
The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the AI Model in determining endoscopic classification of colorectal polyps
Sponsors and contacts
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