UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study of endoscopic image and histological evaluation using Linked Color Imaging regarding to gastric gastritis
Title of the study (Brief title)	The study of endoscopic image and histological evaluation using Linked Color Imaging regarding to gastric gastritis
Region	Japan

Condition
Condition	Atrophic gastritis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To objectively assess whether Linked Color Imaging (LCI) is possible to provide clear and exact image to distinguish endoscopic mucosal atrophic border and to clarify what the color tone of LCI reflects histologically
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We quantify the colors of atrophic mucosa and non-atrophic mucosa in the region of endoscopic mucosal atrophic border and compare the colors between observations by normal light image and by LCI
Key secondary outcomes

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	Diagnosis
Type of intervention	Other
Interventions/Control_1	We will perform a biopsy on atrophic mucosa and non-atrophic mucosa in the region of endoscopic mucosal atrophic border. In addition, We will perform a biopsy on some characteristic gastric mucosal changes.
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. A case diagnosed atrophic gastritis by esophagogastroduodenography
Key exclusion criteria	1) A case who have diseases which cause a large impact on gastric mucosa such as liver cirrhosis or amyloidosis 2) A case who takes Non-steroidal anti-inflammatory drugs or steroid 3) A case who can't stop taking antithrombotic drug 4) a case to be judged unsuitable
Target sample size	60

Research contact person
Name of lead principal investigator	Kazuhiro Mizukami
Organization	Oita university
Division name	Department of Gastroenterology
Address	1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Oita
TEL	097-586-6193
Email	mizkaz0809@oita-u.ac.jp

Public contact
Name of contact person	Kazuhiro Mizukami
Organization	Oita university
Division name	Department of Gastroenterology
Address	1-1, Idaigaoka, Hasama, Yufu, Oita, 879-5593, Oita
TEL	097-586-6193
Homepage URL
Email	mizkaz0809@oita-u.ac.jp

Sponsor
Institute	Department of Gastroenterology, Oita university
Institute
Department

Funding Source
Organization	Department of Gastroenterology, Oita university
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 13 Day
Anticipated trial start date	2015 Year 07 Month 13 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	2016 Year 03 Month 14 Day
Last modified on	2018 Year 03 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024757