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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014453
Receipt No. R000016777
Scientific Title A feasibility study of white opaque substance as visualized magnifying endoscopy for usefulness of endoscopic diagnosis of intestinal metaplasia in the stomach.
Date of disclosure of the study information 2014/07/02
Last modified on 2016/04/27

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Basic information
Public title A feasibility study of white opaque substance as visualized magnifying endoscopy for usefulness of endoscopic diagnosis of intestinal metaplasia in the stomach.



Acronym A feasibility study of white opaque substance as visualized magnifying endoscopy for usefulness of endoscopic diagnosis of intestinal metaplasia in the stomach.
Scientific Title A feasibility study of white opaque substance as visualized magnifying endoscopy for usefulness of endoscopic diagnosis of intestinal metaplasia in the stomach.



Scientific Title:Acronym A feasibility study of white opaque substance as visualized magnifying endoscopy for usefulness of endoscopic diagnosis of intestinal metaplasia in the stomach.
Region
Japan

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

Objectives
Narrative objectives1 The aims of our study is to investigate whether the presence of white opaque substance as detected using ME-NBI is an effective marker for the diagnosis of the histological intestinal metaplasia.
Basic objectives2 Others
Basic objectives -Others To investigate histological characteristics of white opaque substance positive intestinal metaplasia
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in the incidence of histological intestinal metaplasia in the White opaque substance-positive and White opaque substance-negative gastric mucosa.
Key secondary outcomes Histological characteristics of white opaque substance positive intestinal metaplasia

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
Device,equipment
Interventions/Control_1 Magnifing endoscopy with narrow-band imaging
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 with age or more 20 years old, who gave written informed consent.
Key exclusion criteria 1. The patients on anticoagulant or antiplatelet agents who can&#39;t be perfomed the biopsy.
2. The patients who have the lesions with erosion, ulceration or bleeding which disturb the endoscopic observation of surface morphology.
3. The patients with serious underlying disorders.
4. The patients with past history of gastorectomy
5. The patients that were determined to be inappropriate to participate in the study by the investigators.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenshi Yao
Organization Fukuoka University Chikushi Hospital
Division name Depatrtment of Endoscopy
Zip code
Address 1-1-1, Zokumyoin, Chikushino-city, Fukuoka
TEL 092-921-1011
Email yao@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takao Kanemitsu
Organization Fukuoka University Chikushi Hospital
Division name Department of Gastroenterology
Zip code
Address 1-1-1, Zokumyoin, Chikushino city, Fukuoka, Japan
TEL 092-921-1011
Homepage URL
Email t.kanemitsu93@gmail.com

Sponsor
Institute Fukuoka University Central institute for Endoscopy
Institute
Department

Funding Source
Organization Fukuoka University Central institute for Endoscopy
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 福岡大学筑紫病院 (福岡県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 02 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 Completed
Date of protocol fixation
2014 Year 05 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2016 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 02 Day
Last modified on
2016 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016777

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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