UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035386 |
|---|---|
| Receipt number | R000040320 |
| Scientific Title | Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees |
| Date of disclosure of the study information | 2019/01/11 |
| Last modified on | 2025/01/28 19:57:44 |
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Basic information
Public title
Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees
Acronym
LCI-D
Scientific Title
Prospective exploratory study about the laser endoscopy findings of duodenal epithelium in medical examinees
Scientific Title:Acronym
LCI-D
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical features about the difference of the duodenal epithelium color by LCI (linked color imaging) about the medical examenees with gastroscopy
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The color of duodenal epithelium with LCI and the color difference of duodenal epithelium compared WLI (white light imaging) and LCI about medical examenees with gastroscopy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical examinees with gastroscopy at Ebisu Heart Building Clicnic
Key exclusion criteria
1) Examinees who has been performed the operation of upper gastrointestine
2) Examinees who has gastrointestinal heredital diseases including familial adenomatous polyposis and hereditary non-polyposis colorectal cancer
3) Examinees who has severe organ failure
4) Examinees who is considered ungrammatical by the endoscopists
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Kato |
Organization
Keio university, School of medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
1608582
Address
35, Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3437
moto28hiko@icloud.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Nakayama |
Organization
Keio university, School of medicine
Division name
Cancer center
Zip code
1608582
Address
35, Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3437
Homepage URL
anakayama34@keio.jp
Sponsor or person
Institute
Ebisu heart building clinic
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
Ethics Comittee of Japan Gastointestinal Endoscopy Society
Address
3-2-1-4F, Kanda-Surugadai, Chiyoda-ku, Tokyo
Tel
03-3525-4670
jges-rinri@jges.or.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
| 2019 | Year | 01 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
1200
Results
Multiple regression analysis revealed R2=0.04 (p<0.01), and gender ((Beta)=0.5847, p<0.0001) and MetS ((Beta)=0.4138, p=0.0012) as factors independently affecting VAS. Only (Delta)a*, a color index of change in the degree of redness, showed a statistically significant positive correlation with (Delta)VAS (r=0.4529, p<0.0001) Further examination of MetS revealed that significantly more cases met MetS diagnostic criteria when (Delta)VAS > 0 compared to (Delta)VAS < 0 (15.2% vs. 8.1%, odds ratio 2.02, p<0.01).
Results date posted
| 2025 | Year | 01 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 01 | Month | 13 | Day |
Baseline Characteristics
The median age was 47 years, and 69.7% of the patients were male due to the high number of physical examinations provided by their workplaces. NSAIDs were taken by 1.0%, antithrombotic medications by 1.9%, and PPIs by 2.7%. 8.9% of the Hp patients were currently infected and 17.6% were already infected. The median pepsinogen I/II ratio was 5.2. Metabolic syndrome (MetS) diagnostic criteria were met in 10.3% of the patients.
Participant flow
1200 patients were prospectively entered and 56 dropped out due to incomplete imaging or gastrointestinal disease identified after entry. Finally, 1144 patients were included in the analysis.
Adverse events
None
Outcome measures
Seven gastrointestinal endoscopists observed the duodenal bulb with white light observation (WLI) and LCI and evaluated the degree of redness on a visual analog scale (VAS) from 0 to 100 (0: pure white, 50: equal to background mucosa, 100: pure red). This was defined as the amount of change in the perception of redness by the endoscopist. All images were quantified by L*a*b* color space. Values for color difference ((Delta) E*, (Delta) L*, (Delta) a*, (Delta) b*) were calculated from two images, WLI and LCI. (Delta) VAS and patient background and examination outcome factors (age, gender, height, weight, antithrombotic medication use, proton pump inhibitor use, Helicobacter pylori infection status, pepsinogen I/II ratio, Metabolic Syndrome (MetS) diagnostic criteria), and correlations between (Delta) VAS and (Delta) E*, (Delta) L*, (Delta) a*, and (Delta) b* were also examined.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 28 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2025 | Year | 01 | Month | 28 | Day |
Other
Other related information
Entry was delayed due to the COVID 19.
Management information
Registered date
| 2018 | Year | 12 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040320
