Unique ID issued by UMIN | UMIN000042432 |
---|---|
Receipt number | R000048064 |
Scientific Title | 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) |
Date of disclosure of the study information | 2020/11/12 |
Last modified on | 2022/11/01 11:59:51 |
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)
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)
Japan | Asia(except Japan) |
Colorectal adenoma or polyp
Gastroenterology |
Others
NO
This study aims to evaluate whether LCI is superior to the conventional white light image in terms of adenoma detection rate (ADR) in screening or surveillance colonoscopy.
Efficacy
Confirmatory
Pragmatic
Phase III
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.
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Prevention
Device,equipment |
Whole colonic mucosa is observed by the linked color imaging (LCI).
Whole colonic mucosa is observed by white light imaging (WLI).
40 | years-old | <= |
89 | years-old | >= |
Male and Female
1. Patients who will undergo colonoscopy
2. Age of 40-89 years
3. Performance status (ECOG) 0, 1, or 2
4. Written informed consent
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
3000
1st name | Takuji |
Middle name | |
Last name | Gotoda |
Nihon University School of Medicine
Division of Gastroenterology and Hepatology, Department of Medicine
101-8309
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
03-3293-1711
takujigotoda@yahoo.co.jp
1st name | Sho |
Middle name | |
Last name | Suzuki |
Nihon University School of Medicine
Division of Gastroenterology and Hepatology, Department of Medicine
101-8309
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
03-3293-1711
s.sho.salubriter.mail@gmail.com
Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine
Nihon University School of Medicine
Self funding
Institutional Review Board of Nihon University Hospital
1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan
03-3293-1711
nuhosp.rinri@nihon-u.ac.jp
NO
Nihon University School of Medicine, Nagoya University Graduate School of Medicine, Kyoto Prefectural University of Medicine, Jichi Medical University, Yuri Kumiai General Hospital, SingHealth (Changi General Hospital), Tan Tock Seng HP, National Taiwan University Hospital Cancer Center, Rajavithi hospital, Chulalongkorn University, Phramongkutklao Hospital, College of Medicine, Fu Jen Catholic University Hospital, Korea University Ansan Hospital.
2020 | Year | 11 | Month | 12 | Day |
Published
https://www.cghjournal.org/article/S1542-3565(22)01010-2/fulltext
3050
Completed
2020 | Year | 10 | Month | 11 | Day |
2020 | Year | 11 | Month | 12 | Day |
2020 | Year | 11 | Month | 17 | Day |
2022 | Year | 01 | Month | 31 | Day |
2022 | Year | 03 | Month | 28 | Day |
2022 | Year | 03 | Month | 28 | Day |
2020 | Year | 11 | Month | 12 | Day |
2022 | Year | 11 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048064
Research Plan | |
---|---|
Registered date | File name |
2022/03/28 | Protocol_ATLAS trial.pdf |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |
2022/09/16 | ATLAS data (Sep 6, 2022).xlsx |