UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026659 |
|---|---|
| Receipt number | R000030349 |
| Scientific Title | Diagnosis of intestinal metaplasia in gastric mucosa uning Blue Laser Imaging(BLI) |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/03/23 11:02:02 |
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Basic information
Public title
Diagnosis of intestinal metaplasia in gastric mucosa uning Blue Laser Imaging(BLI)
Acronym
Japan BLI intestinal metaplasia Study
Scientific Title
Diagnosis of intestinal metaplasia in gastric mucosa uning Blue Laser Imaging(BLI)
Scientific Title:Acronym
Japan BLI intestinal metaplasia Study
Region
| Japan |
Condition
Condition
Stomach tumor-related lesion
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clarify the usefulness of BLI images to diagnose intestinal metaplasia in the background mucosa during the detailed examination of gastric tumor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric biopsied specimens will be taken from the green change mucosa suspicious of intestinal metaplasia by BLI images, compared with white light images. Similarly, specimens will be taken from brown change mucosa suspicious of non-intestinal metaplasia. Based on the pathological findings, sensitivity, specificity and accuracy will be evaluated.
Key secondary outcomes
Based on histological assessment of endoscopically resected specimens, the usufulness of BLI will be evaluated about the extent of tumor by color contrast between the tumor and the surrounding mucosa. In additon, the color difference will be measured using a color space International Lighting Commission recommended in 1976 in order to quantify such color contast and assess visibility of tumors by BLI.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Pathological diagnosis with endoscopy.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Over the 20 years old
2) Patient with gastric tumor acompanied by chronic gastric inflammatory mucosa.
Key exclusion criteria
1) Acute abdomen
2) Severe inflammation
3) Poor general condition patients who has risk for performing endoscopy such as ileus, perforation of intestine, pancreatitis respiratory disorder, heart failure, acquired hemophilia, stricture and large ulcer or tumor of digestive tract.
4) Patients who take peroral multiple drugs including anti-platelets and anti-coagulants, leading to difficulty to take a biopsy.
5) Patients who experienced entry of this study.
6) Patiens who is judged to be unsuitable for this clinical trial.
7) Patients who are difficult to be received the informed consent.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Osawa, M.D., Ph.D. |
Organization
Jichi Medical University
Division name
Division of Gastroenterology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498 JAPAN
TEL
0285-58-7539
osawa@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Okada, M.D. |
Organization
Jichi Medical University
Division name
Division of Gastroenterology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498 JAPAN
TEL
0285-58-7539
Homepage URL
r0811mo@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM MEDICAL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
Completed
Date of protocol fixation
| 2012 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2017 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030349
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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