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Asian randomized control trial for the efficacy of linked color imaging system for adenoma and polyp detection rates in screening or surveillance colonoscopy (ATLAS trial)

Asian randomized control trial for the efficacy of linked color imaging system for adenoma and polyp detection rates in screening or surveillance colonoscopy (ATLAS trial) - Asian randomized control trial for the efficacy of linked color imaging system for adenoma and polyp detection rates in screening or surveillance colonoscopy (ATLAS trial)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000042432
Enrollment
3000
Registered
2020-11-12
Start date
2020-11-17
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

Colorectal adenoma or polyp

Interventions

Whole colonic mucosa is observed by the linked color imaging (LCI). Whole colonic mucosa is observed by white light imaging (WLI).

Sponsors

Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine
Lead Sponsor

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. History of colorectal surgery (The only appendectomy is acceptable) 2. Known inflammatory bowel disease 3. Known hereditary or non- hereditary polyposis syndrome 4. Known hereditary non-polyposis colorectal cancer (HNPCC) 5. Known severe diverticular segment which restricts total colonoscopy 6. Cannot stop antiplatelet or anticoagulant drugs during colonoscopy 7. Allergy to any drugs used during colonoscopy 8. Known colorectal adenoma, polyp, or cancer before the trial 9. Pregnancy 10. Breast-feeding 11. Lack of informed consent 12. Others

Design outcomes

Primary

MeasureTime frame
The primary outcome is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis), between LCI and white light image groups.

Secondary

MeasureTime frame
1. The polyp detection rate (PDR), defined as the proportion of participants with at least one polyp at a per-patient analysis. 2. The advanced ADR, defined as the proportion of participants with at least one advanced adenoma at a per-patient analysis. 3. The SSL-DR, defined as the proportion of participants with at least one SSL at a per-patient analysis. 4. 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. 5. The mean number of adenomas per patient. 6. The mean number of polyps per patient. 7. The mean number of advanced adenomas per patient. 8. The mean number of SSLs per patient. 9. mean number of proximal adenomas per patient 10. The adenoma or polyp detection rate according to clinicopathological characteristics of the lesions. 11. The adenoma or polyp detection rate according to the experience of colonoscopists. 12. The adenoma or polyp detection rate with or without sedation. 13. The adenoma or polyp detection rate with or without antispasmodics. 14. The adenoma or polyp detection rate according to the endoscopic system (laser system or LED system). 15. The adenoma or polyp detection rate according to the bowel preparation scale. 16. The adenoma or polyp detection rate according to observation time. 17. Adverse event rates.

Countries

Japan,Asia(except Japan)

Contacts

Public ContactSho Suzuki

Nihon University School of Medicine Division of Gastroenterology and Hepatology, Department of Medicine

s.sho.salubriter.mail@gmail.com03-3293-1711

Outcome results

None listed

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