UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026491 |
|---|---|
| Receipt number | R000030410 |
| Scientific Title | Prospective study of the comparison of the image enhanced endoscope in the endoscopic diagnosis of gastric cancer after Hp eradication |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2026/09/12 13:12:13 |
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Basic information
Public title
Prospective study of the comparison of the image enhanced endoscope in the endoscopic diagnosis of gastric cancer after Hp eradication
Acronym
the comparison of the image enhanced endoscope
Scientific Title
Prospective study of the comparison of the image enhanced endoscope in the endoscopic diagnosis of gastric cancer after Hp eradication
Scientific Title:Acronym
the comparison of the image enhanced endoscope
Region
| Japan |
Condition
Condition
gastric cancer or adenoma after Hp eradication
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It examines the visibility of superiority or inferiority of gastric cancer or adenoma after Hp eradication in normal white light and the respective image enhanced endoscope using movie, aimed to reveal the appropriate selection and diagnostic methods of image enhanced endoscope.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visibility for gastric cancer or adenoma after Hp eradication using endoscopic video
Key secondary outcomes
Relation between cancer visibility and clinicopathlogical features
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
The case with gastric cancer or adenoma after Hp eradication who will undergo endoscopic examination at Kyoto Prefectural University of Medicine and relative institutions.
Key exclusion criteria
Cases that principal investigator has determined to be inappropriate for this study.
Cases who are less than 20 years old
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kaji-cho, Kamijyo-ku, Kyoto, Japan
TEL
075-251-5519
syokanai@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Dohi |
Organization
Kyoto Prefectural University of Medicine
Division name
Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kaji-cho, Kamijyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
osamu-d@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kaji-cho, Kamijyo-ku, Kyoto, Japan
Tel
075-251-5337
rinri@koto.kpu-m.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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC8397151/
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC8397151/
Number of participants that the trial has enrolled
30
Results
LCI improved nonmagnified EGC visibility versus WLI with scores of 3.35 and 2.91. Magnifying BLI best showed microsurface and microvascular patterns supporting LCI detection followed by BLI diagnosis.
Results date posted
| 2026 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 31 patients with EGC after successful HP eradication. Mean age was 72.1 years and 54.8 percent were men. Mean time after eradication was 5.58 years. Mean tumor size was 21.2 mm and 87.1 percent were differentiated cancers.
Participant flow
Four centers enrolled 33 patients scheduled for ESD after successful HP eradication. Two ineligible patients were excluded after video recording leaving 31 for analysis. Three endoscopists assessed randomized WLI BLI and LCI videos.
Adverse events
None
Outcome measures
The primary endpoint was visibility of EGC after HP eradication. The secondary endpoint was visibility of Kyoto classification findings including atrophy intestinal metaplasia and maplike redness. Findings were scored from 1 to 4.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The LED light source WLI / LCI and the laser light source WLI / LCI are blindly randomized, and the endoscopist assesses the visibility of each image on a 4-point scale from 4 to 1. Using the visibility score to compare the visual superiority of LCI against WLI and the non-inferiority of LCI's visual superiority between LED and laser light source.
Management information
Registered date
| 2017 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030410
