Randomised trial examining the sessile serrated lesion detection rate using linked color imaging in combination with an artificial intelligence assisted colonoscopy.

Randomised trial examining the sessile serrated lesion detection rate using linked color imaging in combination with an artificial intelligence assisted colonoscopy. - Randomised trial examining the sessile serrated lesion detection rate using linked color imaging in combination with an artificial intelligence assisted colonoscopy.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000053777

Enrollment

2000

Registered

2024-03-10

Start date

2024-04-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sessile serrated lesion or Colorectal polyp

Interventions

Whole colonic mucosa is observed by the linked color imaging (LCI). Whole colon mucosa is observed by a combination of linked color imaging (LCI) and computer-aided detection.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who will undergo colonoscopy 2. Age of 40-89 years 3. Performance status (ECOG) 0, 1, or 2 4. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Whole colonoscopy not scheduled 2. History of colorectal surgery (The only appendectomy is acceptable) 3. Known colorectal adenoma, polyp, or cancer before the trial 4. Known inflammatory bowel disease 5. Known hereditary or non- hereditary polyposis syndrome 6. Difficulty in completing observation of the mucosa of the whole colon 7. Difficult to collect pathology tissue 8. Already participating in this study 9. Others

Design outcomes

Primary

Measure	Time frame
The primary outcome is the SSL detection rate, defined as the proportion of participants with at least one SSL.	—

Secondary

Measure	Time frame
1. The adenoma detection rate (ADR), defined as the proportion of participants with at least one polyp at a per-patient analysis. 2. The polyp detection rate (PDR), defined as the proportion of participants with at least one polyp at a per-patient analysis. 3. The advanced ADR, defined as the proportion of participants with at least one advanced adenoma at a per-patient analysis. 4. The TSA-DR, defined as the proportion of participants with at least one TSA at a per-patient analysis. 5. The proximal ADR, defined as the proportion of participants with at least one adenoma at the proximal colon (cecum to transverse colon) at a per-patient analysis. 6. The mean number of adenomas per patient. 7. The mean number of polyps per patient. 8. The mean number of advanced adenomas per patient. 9. The mean number of SSLs per patient. 10. The mean number of TSAs per patient. 11. The adenoma or polyp detection rate according to clinicopathological characteristics of the lesions. 16. Observation time. 17. Adverse event rates.	—

Measure

Time frame

1. The adenoma detection rate (ADR), defined as the proportion of participants with at least one polyp at a per-patient analysis. 2. The polyp detection rate (PDR), defined as the proportion of participants with at least one polyp at a per-patient analysis. 3. The advanced ADR, defined as the proportion of participants with at least one advanced adenoma at a per-patient analysis. 4. The TSA-DR, defined as the proportion of participants with at least one TSA at a per-patient analysis. 5. The proximal ADR, defined as the proportion of participants with at least one adenoma at the proximal colon (cecum to transverse colon) at a per-patient analysis. 6. The mean number of adenomas per patient. 7. The mean number of polyps per patient. 8. The mean number of advanced adenomas per patient. 9. The mean number of SSLs per patient. 10. The mean number of TSAs per patient. 11. The adenoma or polyp detection rate according to clinicopathological characteristics of the lesions. 16. Observation time. 17. Adverse event rates.

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Countries

Japan

Contacts

Public ContactToshiki Horii

Kitasato university Department of Gastroenterology

horiitoshiki@gmail.com+81-42-778-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026