UMIN-CTR Clinical Trial

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
Email	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
Email	ishikawa.tsubasa@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049114