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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024744
Receipt No. R000028468
Scientific Title The research of a gastric mucosal color change using linked color imaging (LCI) and the histologic and serologic change after Helicobacter pylori eradication
Date of disclosure of the study information 2016/11/07
Last modified on 2016/11/07

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Basic information
Public title The research of a gastric mucosal color change using linked color imaging (LCI) and the histologic and serologic change after Helicobacter pylori eradication
Acronym The research of a gastric mucosal color change using linked color imaging (LCI) and the histologic and serologic change after Helicobacter pylori eradication
Scientific Title The research of a gastric mucosal color change using linked color imaging (LCI) and the histologic and serologic change after Helicobacter pylori eradication
Scientific Title:Acronym The research of a gastric mucosal color change using linked color imaging (LCI) and the histologic and serologic change after Helicobacter pylori eradication
Region
Japan

Condition
Condition Helicobacter pylori-associated active gastritis
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify usefulness of LCI in Helicobacter pylori infection diagnosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Difference of color value of white light and LCI befor and after H. pylori eradication
Key secondary outcomes Correlation between LCI findings, histological and serological findings

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 a)The patients diagnosed as H. pylori associated gastritis.
b)The patients will undergo endoscopy.
c)The patients will undergo H. pylori eradication.
Key exclusion criteria a)Patients with anticoagulant drug without aspirin
b)Patients with MALT lymphoma
c)Patients with liver cirrhosis
d)Patients with renal failure
e)Patients under the pregnancy
f)nursing patients
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Okada
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho Kita-ku Okayama, Japan
TEL 086-235-7219
Email ftryr059@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ko Miura
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho Kita-ku Okayama, Japan
TEL 086-235-7219
Homepage URL
Email ftryr059@yahoo.co.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2016 Year 11 Month 07 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
Date of protocol fixation
2015 Year 11 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2016 Year 11 Month 07 Day
Last modified on
2016 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028468

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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