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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026659
Receipt No. 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

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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
Email 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
Email r0811mo@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030349

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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