UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024744 |
|---|---|
| Receipt number | 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 20:13:18 |
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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
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
ftryr059@yahoo.co.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028468
