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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029629
Receipt No. R000033846
Scientific Title Clinical usefulness of endoscopic assessment in ulcerative colitis using linked color imaging: a preliminary pilot study.
Date of disclosure of the study information 2017/10/19
Last modified on 2018/06/06

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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
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 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
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 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
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
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
Registered date File name

Research case data
Registered date File name


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