UMIN-CTR Clinical Trial

Basic information
Public title	Clinical usefulness of endoscopic assessment in ulcerative colitis using linked color imaging: a preliminary pilot study.
Acronym	Evaluation of inflammation of ulcerative colitis using LCI.
Scientific Title	Clinical usefulness of endoscopic assessment in ulcerative colitis using linked color imaging: a preliminary pilot study.
Scientific Title:Acronym	Evaluation of inflammation of ulcerative colitis using LCI.
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the usefulness of Linked Color Imaging (LCI) to evaluate the activity of mucosal inflammation in ulcerative colitis (UC) patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1.The color differences (delta C) were calculated among WLI and LCI. 2.Correlation between the color differences (delta C) and pathological findings.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
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Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	1.Ulcerative colitis patient 2.Inactive or mildly active UC
Key exclusion criteria	1.Severe or fluminant UC 2.The patients with antithrombotic agents 3.The patients with malignant tumor 4.When the physicians judge that it is inappropriate to be included in this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kohei Yamanouchi
Organization	Takagi hospital Saga Medical School
Division name	Internal Medicine & Gastrointestinal Endoscopy
Zip code
Address	141-11 Oazasakemi Okawa Fukuoka, Japan
TEL	0944-87-0001
Email	kymstd@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Kohei Yamanouchi
Organization	Saga Medical School
Division name	Internal Medicine & Gastrointestinal Endoscopy
Zip code
Address	5-1-1 Nabeshima Saga Saga, Japan
TEL	0952-31-6511
Homepage URL
Email	kymstd@yahoo.co.jp

Sponsor
Institute	Saga Medical School
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	佐賀大学附属病院(佐賀県)

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 19 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
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 10 Month 19 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded

Other

Other related information

All examinations were conducted with a LASEREO endoscopic system (FUJIFILM CO., Tokyo, Japan). During the colonoscopy, each region of interest (ROI) of terminal ileum, cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum was observed by both white light imaging (WLI), and LCI. The Commission international de l'eclairage (CIE) LAB color differences (delta C) were calculated among WLI and LCI in each ROI. After ROI was observed by colonoscopy, the biopsy specimen was taken in each ROI. The correlation between delta C and pathological findings was assessed.

Management information
Registered date	2017 Year 10 Month 19 Day
Last modified on	2018 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033846

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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