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RecruitingNCT06791408Updated Mar 7, 2025

Clinical Study on the Accuracy of Real-time AI-assisted Endocytoscopy in the Diagnosis of Colorectal Diminutive Polyps

An observational study in Colorectal Polyp, sponsored by The First Hospital of Jilin University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2025-03-07.

Sponsored by The First Hospital of Jilin University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Feb 2025; still recruiting 1 year 9 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
600
Sex
All
01

Study summary

Colorectal cancer (CRC) is the third most common malignant tumor in the world and the second largest cause of cancer-related death [1]. Colonoscopy is considered the preferred method of screening for colorectal cancer, and early and resectable detection of colorectal neoplastic lesions can significantly reduce colorectal cancer morbidity and mortality. In recent years, with the continuous development of endoscopic diagnostic techniques and the standardization and strengthening of endoscopist training, the detection rate of colorectal polyps has increased year by year. As the number of endoscopic excisions increases, the costs associated with endoscopic excision and pathological diagnosis of excised specimens increase year by year. Research results showed that about 90% of the detected polyps were small polyps (6-9 mm) and diminutive polyps (≤5 mm), and nearly half of them were non-neoplastic polyps, so endoscopic resection and histopathological examination were not required [2, 3]. In order to reduce unnecessary pathological examination and endoscopic treatment, the American Society of Digestive Endoscopy proposed PIVI strategies: "excise and discard" and "diagnose and do not excise" strategies.

Endocytoscopy is a kind of ultra-high magnification endoscopy. Combined with chemical staining and narrow-band imaging technology, endoscopists can observe and judge the nuclear morphology, glandular duct morphology and microvascular morphology of colorectal lesions by naked eye, thus realizing the purpose of real-time biopsy in vivo. However, it takes a lot of experience accumulation to improve the judgment accuracy of endoscopy images, and endoscopy doctors have certain subjective judgments and errors in the process of judging results. Therefore, in order to solve this problem, Artificial Intelligence (AI) is proposed clinically. Our center has developed an artificial intelligence assisted diagnosis system based on endocytoscopy to assist endocytoscopy in judging the nature of colorectal lesions. However, whether this artificial intelligence assisted diagnosis system is accurate in judging the nature of colorectal diminutive polyps and is suitable for widespread promotion and application of PIVI strategy lacks relevant clinical data. This study intends to carry out this clinical study to verify the diagnostic accuracy of this artificial intelligence in the diagnosis of colorectal diminutive polyps.

02

Conditions studied

  • Colorectal Polyp

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03

In context

Polyps

312 studies on the registry are indexed under Polyps; 60 are open to participants now.

This study's planned enrollment of 600 is above the median of 209 across 101 observational studies indexed under Polyps.

Browse Polyps studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 185 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with colorectal lesions

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • colorectal lesions

Exclusion criteria

Exclusion Criteria:

  • lesions lacking high-quality images;
  • Inflammatory bowel disease, familial adenomatous polyposis and other special diseases;
  • submucosal tumors;
  • Pathological diagnosis of inflammatory polyps, Peutz-Jeghers polyps, juvenile polyps, lymphoma and other pathological types.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Negative predictive value

    Time frame: 2025-12-31

  2. sensitivity

    Time frame: 2025-12-31

  3. specificity

    Time frame: 2025-12-31

  4. accurary

    Time frame: 2025-12-31

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06791408
Responsible party
Sponsor
First posted
Jan 24, 2025
Start date
Feb 5, 2025
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Mar 7, 2025

Study contacts

Mingqing Liu, Docror
Contact
liumq23@mails.jlu.edu.cn
+8613204300453
Hong Xu, Docror
principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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