UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of differences of color between intestinal metaplasia and background mucosa using Linked Color Imaging (LCI)
Title of the study (Brief title)	Diagnosis of intestinal metaplasia using LCI
Region	Japan

Condition
Condition	Helicobacter pylori-induced gastritis
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the differences of color between the gastric mucosa with or without intestinal metaplasia using LCI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences of color between white-light imaging and LCI in the lesions with or without intestinal metaplasia.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients who hope endoscopic diagnosis of H. pylori-induced gastritis including gastric biopsy in Hokkaido University Hospital are included. 1. the patients who are 20 years or older at the agreement acquisition 2. the patients receive endoscopy using LCI
Key exclusion criteria	The patients who can not receive biopsy for background disease or use of antithrombotic drugs
Target sample size	128

Research contact person
Name of lead principal investigator	Shoko Ono
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Address	Nishi-5, Kita-14, Kita-ku, Sapporo 060-8638, Japan
TEL	0117161161
Email	onosho@med.hokudai.ac.jp

Public contact
Name of contact person	Shoko Ono
Organization	Hokkaido University Hospital
Division name	Division of Endoscopy
Address	Nishi-5, Kita-14, Kita-ku, Sapporo 060-8638, Japan
TEL	0117161161
Homepage URL
Email	onosho@med.hokudai.ac.jp

Sponsor
Institute	Division of Endoscopy, Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Division of Endoscopy, Hokkaido University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 29 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 02 Month 23 Day
Anticipated trial start date	2016 Year 03 Month 11 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	Published
URL releasing results
Results
Other related information	Prospective study using gastric biopsy specimen. The patients who receive upper endoscopy including H. pylori infection status. Cross sectional method, all the patients who meet our criteria between March 2016 and August 2017. Measurement:endoscopic images(white light and LCI), H. pylori tests, biopsies.

Management information
Registered date	2016 Year 02 Month 25 Day
Last modified on	2018 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024440