UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045323 |
|---|---|
| Receipt number | R000051060 |
| Scientific Title | Efficacy of Texture and Color Enhancement Imaging for esophagogastroduodenoscopy |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2026/03/05 14:48:29 |
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Basic information
Public title
Efficacy of Texture and Color Enhancement Imaging for esophagogastroduodenoscopy
Acronym
TXI for EGD
Scientific Title
Efficacy of Texture and Color Enhancement Imaging for esophagogastroduodenoscopy
Scientific Title:Acronym
TXI for EGD
Region
| Japan |
Condition
Condition
the Kyoto Classification of Gastritis, Laryngitis, lesions of the gastroesophageal junction, vascular lesion, neoplastic lesion, autoimmune gastritis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of TXI compared with white light imaging.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of visibility between WLI and TXI in upper GI lesions.
Key secondary outcomes
Evaluation of diagnostic ability and color difference with TXI in upper GI lesions.
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
Patients with gastrointestinal lesions who underwent esophagogastroduodenoscopy with TXI and WLI.
Key exclusion criteria
Patients who had a history of gastrectomy or esophageal surgery, and patients for whom endoscopic examination was considered difficult because of serious hepatic, heart, or respiratory diseases.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Takeda |
Organization
Juntendo university school of medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku
TEL
03-3813-3111
t-takeda@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Takeda |
Organization
Juntendo University school of Medicine
Division name
Department of Gastroenterology
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku
TEL
0338133111
Homepage URL
t-takeda@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University school 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
Juntendo University school of Medicine Ethics Committee
Address
3-1-3 Hongo, Bunkyo-ku
Tel
03-5802-1584
kenkyu5858@juntendo.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
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://medscimonit.com/abstract/full/idArt/940249, https://doi.org/10.1002/deo2.70297
Number of participants that the trial has enrolled
220
Results
TXI-1 improved the visibility of diffuse redness, spotty redness, map-like redness, patchy redness, atrophic border, red streak, and the RAC. Visibility of intestinal metaplasia was also enhanced by TXI-1, although the degree of improvement was smaller than that observed for other findings. Inter-rater reliability for TXI-1 was moderate to substantial. In addition, objective colorimetric analysis demonstrated significantly greater delta E values with TXI-1 than with WLI for map-like redness.
Results date posted
| 2026 | Year | 03 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 13 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 01 | Month | 14 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2021 | Year | 08 | Month | 31 | Day |
Last modified on
| 2026 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051060
