Clinical trial NCT06773832: AI in Predicting Polyp Pathology and Endoscopic Classification
Official title: Artificial Intelligence Predicts the Pathology and Endoscopic Classification of Colorectal Polyps During Colonoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Polyps
Keywords: Colonoscopy
Artificial Intelligence
Optical Diagnosis
Sessile Serrated Adenoma
Adenoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 18 years or older undergoing routine colonoscopy screening

Brief summary: 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: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Accuracy of Optical Diagnosis for Colorectal Polyps
timeFrame: 2 years
Secondary outcomes:
measure: Other Assessment Parameters of Optical Diagnosis
timeFrame: 2 years
measure: Accuracy in Determining Endoscopic Classification of Colorectal Polyps
timeFrame: 2 years
measure: Other Assessment Parameters in Determining Endoscopic Classification
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Dong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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