UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis of intestinal metaplasia in gastric mucosa uning Blue Laser Imaging(BLI)
Title of the study (Brief title)	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	Hiroyuki Osawa, M.D., Ph.D.
Organization	Jichi Medical University
Division name	Division of Gastroenterology
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498 JAPAN
TEL	0285-58-7539
Email	osawa@jichi.ac.jp

Public contact
Name of contact person	Masahiro Okada, M.D.
Organization	Jichi Medical University
Division name	Division of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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