UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017990
Receipt number R000020847
Scientific Title Assessment of endoscopic mucosal healing of inflammatory bowel disease using linked color imaging (LCI), a novel endoscopic enhancement system
Date of disclosure of the study information 2015/08/01
Last modified on 2023/12/30 21:51:40

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Basic information

Public title

Assessment of endoscopic mucosal healing of inflammatory bowel disease using linked color imaging (LCI), a novel endoscopic enhancement system

Acronym

The usefulness of LCI for endoscopic diagnosis of inflammatory bowel disease

Scientific Title

Assessment of endoscopic mucosal healing of inflammatory bowel disease using linked color imaging (LCI), a novel endoscopic enhancement system

Scientific Title:Acronym

The usefulness of LCI for endoscopic diagnosis of inflammatory bowel disease

Region

Japan


Condition

Condition

Inflammatory bowel disease

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Mucosal healing and control of intestinal mucosal inflammation have been reported as important treatment goals for maintaining clinical remission in ulcerative colitis (UC) and Crohn's disease (CD) patients. In this study, we investigated the availability and efficacy of linked color imaging (LCI), a novel endoscopic enhancement system, for the diagnosis of mucosal inflammation in UC and CD patients. Besides, we investigate the usefulness for prediction of prognosis for UC and CD.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase



Assessment

Primary outcomes

Correlation between LCI findings, digitization of LCI and intestinal mucosal inflammation, cytokine mRNA expression.

Key secondary outcomes

Correlation between LCI findings, digitization of LCI and prognosis of UC and CD.


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients diagnosed as ulcerative colitis and Crohn's disease based on the criteria of Japanese Ministry of Health, Specific disease intractable inflammation-related intestinal tract disorder research group.

Key exclusion criteria

a) Re-registration example to the examination
b) The patients with malignant tumor
c) The patients with surgical operation within 12 weeks
d) In addition, the patient who judged an arrangement to the examination if the medical attendant was inappropriate

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Tomohisa
Middle name
Last name Takagi

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan

TEL

075-251-5519

Email

takatomo@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Kazuhiko
Middle name
Last name Uchiyama

Organization

Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code

602-8566

Address

465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5519

Homepage URL


Email

k-uchi@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine

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

Ethics Committee of Kyoto Prefectural University of Medicine, Kyoto Prefectural University of Medicine

Address

465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan

Tel

075-251-5337

Email

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

2015 Year 08 Month 01 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

2014 Year 06 Month 01 Day

Date of IRB

2015 Year 11 Month 20 Day

Anticipated trial start date

2015 Year 11 Month 20 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The image enhancement system used in this study is Fujifilm's new endoscopic image enhancement system, which is a signal processing system for images taken in BLI-bright mode of Fujifilm's LASEREO, which irradiates a mixture of narrow-band light and white light (Linked Color Imaging: LCI). In addition, the degree of redness is analyzed by the distribution of pigments in the L*a*b* system, and by quantifying the a* value which is a component of red, we attempt to objectively express the inflammation of mucosal tissue and endoscopic score.
Biopsies from each site taken in LCI mode (four for histological diagnosis, immunostaining, protein analysis, and mRNA expression analysis in the ileum, sigmoid colon, and rectum, and only one for histopathological diagnosis in other sites).
As for protein and mRNA expression in the biopsy tissues, mRNA and protein expression of genes that have been reported to be related to the pathogenesis of IBD (genes related to the pathogenesis of inflammation, proliferation and re-epithelialization of epithelial cells): cytokines, growth factors, short-chain fatty acid receptors, Wnt-related genes, factors related to inflammation and tissue repair such as VEGF, and microRNAs. Protein expression will be examined by Western blotting or ELISA, and mRNA expression will be examined by real time PCR. The above factors will also be confirmed by immunostaining and in situ hybridization to determine the expression cells. Some of the biopsied tissues will be sequenced for RNA expression by Next Generation Sequencing (NGS) to examine the details of RNA expression and the interrelationship of cytokines and other factors. To predict the long-term prognosis, endoscopy will be performed every year from the time of the initial measurement for up to 8 years, and the same study as above will be performed at that time.


Management information

Registered date

2015 Year 06 Month 20 Day

Last modified on

2023 Year 12 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020847


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name