UMIN-CTR Clinical Trial

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

Colorectal tumor, inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Chiba University

Institute

Department

Personal name

Organization

Chiba University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Chiba University Hospital

Address

1-8-1 Inohana, Chuo-ku, Chiba(260-8677)

Tel

0432262083

Email

ishikawa.tsubasa@chiba-u.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

01

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

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