UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048193 |
|---|---|
| Receipt number | R000054798 |
| Scientific Title | Examination of the detection ability of multiple white flat lesions (MWFL) with narrow band imaging. |
| Date of disclosure of the study information | 2022/06/29 |
| Last modified on | 2022/12/28 14:24:47 |
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Basic information
Public title
Examination of the detection ability of multiple white flat lesions (MWFL) with narrow band imaging.
Acronym
Examination of the detection ability of multiple white flat lesions (MWFL) with narrow band imaging.
Scientific Title
Examination of the detection ability of multiple white flat lesions (MWFL) with narrow band imaging.
Scientific Title:Acronym
Examination of the detection ability of multiple white flat lesions (MWFL) with narrow band imaging.
Region
| Japan |
Condition
Condition
multiple white flat lesions (MWFL)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the use of NBI in upper gastrointestinal endoscopy increases the detection of multiple white flat lesions (MWFL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in the number of MWFL detected at first endoscopy between the WLI and NBI groups.
Key secondary outcomes
1.Difference in the positive rate of MWFL detected at first endoscopy between the WLI and NBI groups.
2.To compare the number and positive rate of MWFL detected by first and second endoscopy in the NBI and WLI groups, and to examine the additional effect of MWFL detection ability in both groups.
3.Differences in MWFL detectability by years of experience of practicing physicians.
4.The relationship between MWFL detectability and the following contents will be examined.
1)oral administration period of PPIs.
2)endoscopic findings (gastric polyps, gastric mucosa findings).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
In the WLI group, the stomach is observed without NBI in the first endoscopy. Immediately after the first endoscopy, the same physician will observe the stomach using NBI.
Interventions/Control_2
In the NBI group, the stomach is observed using NBI in the first endoscopy. Immediately after the first endoscopy, the same physician will observe the stomach without NBI.
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
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients on oral PPIs.
Patients who were over 20 years.
Patients who have given written consent to participate in the study.
Key exclusion criteria
Patients who have risk factor of bleeding after biopsy such as receiving anticoagulation therapy.
Patients who have tendency of easy bleeding such as liver cirrhosis, hemophilia or ITP.
Patients who have history of distal or gastorectomy.
Patients who are not eligible to this study due to psychotic disease or psychological symptoms.
Patients whom doctor decide not to register to this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
818-0067
Address
1-1-1 Zokumyoin, Chikushino city, Fukuoka prefecture
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Takeda |
Organization
Fukuoka University Chikushi Hospital
Division name
Endoscopy
Zip code
818-0067
Address
1-1-1 Zokumyoin, Chikushino city, Fukuoka prefecture
TEL
092-921-1011
Homepage URL
newzealand_greg@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Department of Endoscopy
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Chikushi Hospital
Department of 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
Fukuoka university medical ethics committee
Address
7-45-1 Nanakuma, Jonanku, Fukuoka city, Fukuoka prefecture
Tel
092-801-1011
chikushirinsho@adm.Fukuoka-u.ac.jp
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
| 2022 | Year | 06 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
no related information
Management information
Registered date
| 2022 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054798
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