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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017990
Receipt No. 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 2018/07/15

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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
Middle name
Last name Yuji Naito
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
Address 465 Kajiicho Hirokoji Kawaramachidori Kamigyo-ku Kyoto, Japan
TEL 075-251-5519
Email ynaito@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Uchiyama
Organization Kyoto Prefectural University of Medicine
Division name Molecular Gastroenterology and Hepatology
Zip code
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
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization 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
Address
Tel
Email

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
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information All examinations were carried out with an EG-L590WR endoscope and a LASEREO endoscopic system (FUJIFILM Co., Tokyo, Japan). Blue laser imaging-bright data were converted to LCI by image processing. LCI simultaneously expands and reduces color information so that a reddish color becomes redder, and a whitish color becomes whiter. The red color inside a region of interest (ROI) in the mucosal image is digitized and evaluated by the pathological inflammation and endoscopic scores. Inflammation in the biopsy specimen was evaluated according to Matts biopsy specimen classification. The parts of biopsy and LCI analysis are cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum.
Samples for pathological analysis, protein expression analysis, and mRNA expression analysis will be taken from sigmoid colon. Inflammatory parameters such as TNF-alpha, IFN-gamma, IL-8, IL-6, and TGF-beta expression will be analyzed by real time PCR and ELISA. Short chain fatty acid receptor expression will be measured by real time PCR and Western blotting, as well.
Colonoscopy will be performed one year after the entry, and same examination will be done.

Management information
Registered date
2015 Year 06 Month 20 Day
Last modified on
2018 Year 07 Month 15 Day


Link to view the page
URL(English) https://upload.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


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