UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059058 |
|---|---|
| Receipt number | R000066531 |
| Scientific Title | Efficacy of Linked Color Imaging-Assisted Colonoscopy with Artificial Intelligence for Adenoma Detection Rate without Antispasmodic Use: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/09/14 |
| Last modified on | 2025/09/11 12:50:56 |
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Basic information
Public title
Efficacy of Linked Color Imaging-Assisted Colonoscopy with Artificial Intelligence for Adenoma Detection Rate without Antispasmodic Use: A Multicenter Randomized Controlled Trial
Acronym
ELIAS trial
Scientific Title
Efficacy of Linked Color Imaging-Assisted Colonoscopy with Artificial Intelligence for Adenoma Detection Rate without Antispasmodic Use: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
ELIAS trial
Region
| Japan |
Condition
Condition
Colon polyp
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether observation with CADe under LCI is effective in improving the rate of adenoma detection under poor visual field conditions with intestinal peristalsis by comparing a group of patients without antispasmodic medication who were observed with CADe under LCI observation with a group who were observed with WLI alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adenoma detection rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
LCI/CADe group: observation from the cecum to the rectum is performed using LCI mode with CADe (CAD EYE: Fujifilm Medical Corporation) assistance.
Interventions/Control_2
WLI group: observation from cecum to rectum with normal light.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. persons aged 20 years and over who undergo a planned colonoscopy.
2. persons undergoing colonoscopy with the purpose of examination as "asymptomatic patients, including second-line screening (screening)", "patients with a history of polypectomy and for follow-up purposes (surveillance)" or 'symptomatic scrutiny'
3. patients who do not wish to use or are clinically unable to use the antispasmodic drug butylscopolamine bromide (cardiac disease, history of angle closure glaucoma or glaucoma, benign prostatic hyperplasia, history of hyperthyroidism, drug allergy, etc.)
4. those who do not wish to use or are clinically unable to use the antispasmodic drug glucagon (e.g. history of diabetes, blood glucose and HbA1c not measured by blood sampling within 1 month of the examination and diabetes cannot be ruled out)
5. persons for whom the study has been explained in writing and written consent has been obtained.
Key exclusion criteria
1. those with a history of inflammatory bowel disease
2. persons with active gastrointestinal bleeding
3. who have undergone bowel resection
4. those with a history of familial adenomatous polyposis
5. persons with previously known severe intestinal adhesions
6. any other person who is judged by the principal investigator or principal study investigator to be unsuitable to participate in the study.
Target sample size
210
Research contact person
Name of lead principal investigator
| 1st name | Naohiko |
| Middle name | |
| Last name | Akimoto |
Organization
Nippon Medical School Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
t-habu@nms.ac.jp
Public contact
Name of contact person
| 1st name | Tsugumi |
| Middle name | |
| Last name | Habu |
Organization
Nippon Medical School Hospital
Division name
Department of Gastroenterology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
0338222131
Homepage URL
t-habu@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
0338222131
t-habu@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 09 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066531
