UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029629 |
|---|---|
| Receipt number | 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 | 2020/10/21 09:30:52 |
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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
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
kymstd@yahoo.co.jp
Sponsor or person
Institute
Saga Medical School
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 19 | Day |
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
| 2020 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033846
