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NCT06773832Recruiting

AI in Predicting Polyp Pathology and Endoscopic Classification

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

Source: ClinicalTrials.gov · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
400 (estimated)
First submitted
3 Jan 2025
Start date
Jan 2025
Primary completion date
Dec 2026
Lead sponsor
Peking Union Medical College Hospital
NCT number
NCT06773832

What you commit to

  • Study type: Observational
  • Planned participants: 400
  • From Jan 2025 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have undergone colorectal surgery.

Other illness

  • Known or suspected intestinal obstruction or perforation;
  • Severe congestive heart failure (New York Heart Association Class III or IV);
  • 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;

Lab values

  • Severe chronic renal failure (creatinine clearance less than 30 mL/minute);

Other

  • Gastroparesis or gastric outlet obstruction;
  • Currently pregnant or breastfeeding;
  • Toxic colitis or megacolon;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
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BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.