UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043190 |
|---|---|
| Receipt number | R000049114 |
| Scientific Title | Efficacy of TXI (Texture and Color Enhancement Imaging) Observation in Lower Gastrointestinal Endoscopy |
| Date of disclosure of the study information | 2021/01/31 |
| Last modified on | 2021/01/31 08:20:09 |
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Basic information
Public title
Efficacy of TXI (Texture and Color Enhancement Imaging) Observation in Lower Gastrointestinal Endoscopy
Acronym
TXI study in lower gastrointestinal endoscopy
Scientific Title
Efficacy of TXI (Texture and Color Enhancement Imaging) Observation in Lower Gastrointestinal Endoscopy
Scientific Title:Acronym
TXI study in lower gastrointestinal endoscopy
Region
| Japan |
Condition
Condition
Colorectal tumor, inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This time, Olympus Corporation introduced a new IEE, Texture and Color Enhancement Imaging (TXI). TXI is an imaging technology that separates an image obtained under normal white light into a texture image and a base image, enhances the texture, corrects the color tone and brightness, and then recombines the two images to optimize the three elements of structure, color tone, and brightness of the mucosal surface under normal white light illumination (WLI). TXI is an imaging technology that optimizes the three elements of "structure," "color tone," and "brightness" of the mucosal surface under normal white light illumination (WLI). TXI is a newly introduced IEE, and although it is expected to be useful, there is not much knowledge about its usefulness in actual clinical situations or lesions.
The purpose of this study is to compare the usefulness of TXI, a new IEE, in a wide range of clinical situations and lesions. TXI is expected to enhance and correct the color tone and contour of mucosa, and to clarify subtle changes in mucosal irregularities, redness, and blood vessels that are difficult to distinguish with WLI. In this study, we will conduct a broad forward observational study on the determination of inflammatory mucosa and vascular permeability by UC, borderline diagnosis of colorectal tumors including colorectal adenoma, detection rate of colorectal adenoma in screening tests, and other lesions and inflammatory findings. If we can confirm the usefulness of the data obtained in this study for the detection rate of lesions, borderline diagnosis, and diagnosis of inflammation in screening and scrutiny endoscopy, it is expected to become an important index for endoscopic diagnosis and treatment of colorectal tumors and endoscopic diagnosis of inflammatory bowel diseases such as UC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For patients scheduled for lower gastrointestinal endoscopy (including extended endoscopy for colorectal tumors and endoscopic treatment for colorectal tumors) at our hospital, imaging with WLI, TXI and indigocarmine spraying with normal observation for about 10-20 minutes or diagnosis before treatment (qualitative diagnosis: tumor or non-tumor, boundary Diagnosis: ease of determining the border between tumor and non-tumor areas, inflammatory findings and vascular permeability in case of inflammatory lesions). If endoscopic treatment is to be performed afterwards, the post-treatment pathology results and the preoperative endoscopic diagnosis should be compared at a later date to determine the accuracy of the preoperative diagnosis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing lower gastrointestinal endoscopy at our hospital who can give consent
Key exclusion criteria
Patients for whom consent could not be obtained or for whom appropriate images could not be obtained.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
0432227171
matsumura@chiba-u.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Ishikawa |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
0432262083
Homepage URL
ishikawa.tsubasa@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Chiba University Hospital
Address
1-8-1 Inohana, Chuo-ku, Chiba(260-8677)
Tel
0432262083
ishikawa.tsubasa@chiba-u.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 | 01 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following items will be examined in lower gastrointestinal endoscopy.
Comparison of colorectal tumor detection rate and image visibility between TXI and WLI
Comparison of image visibility between TXI and WLI for various inflammatory findings including inflammatory bowel disease such as UC
Comparison of the usefulness of TXI and WLI for the evaluation of vascular permeability in patients with inflammatory bowel disease such as UC
Comparison of the usefulness of TXI and WLI for other lesions
z Association between patient background and the above endpoints
The relationship between the above endpoints and the history of inflammatory bowel disease treatment according to the medical record.
The association between the above endpoints and the clinical disease status of inflammatory bowel disease by medical record collection
The association of the above endpoints between endoscopists and non-endoscopists
Management information
Registered date
| 2021 | Year | 01 | Month | 31 | Day |
Last modified on
| 2021 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049114
