UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014453 |
|---|---|
| Receipt number | 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 17:12:40 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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'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
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
t.kanemitsu93@gmail.com
Sponsor or person
Institute
Fukuoka University Central institute for Endoscopy
Institute
Department
Personal name
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
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
Value
https://center6.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 |
