UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032323 |
|---|---|
| Receipt number | R000036859 |
| Scientific Title | Randomized controlled study for delineating early gastric cancer by white light imaging (WLI) and narrow-band imaging (NBI) |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2022/10/24 10:54:15 |
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Basic information
Public title
Randomized controlled study for delineating early gastric cancer by white light imaging (WLI) and narrow-band imaging (NBI)
Acronym
NBI-WLI study
Scientific Title
Randomized controlled study for delineating early gastric cancer by white light imaging (WLI) and narrow-band imaging (NBI)
Scientific Title:Acronym
NBI-WLI study
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison between concordance rates of WLI and NBI in delineating early gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison between concordance rates of WLI and NBI in delineating early gastric cancer.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
white light imaging
Interventions/Control_2
narrow-band imaging
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
1) En bloc resection in ESD.
2) Histopathological diagnosis is gastric cancer.
3) Gastric cancer within a diameter of 30mm.
Key exclusion criteria
1) Histopathological diagnosis is impossible due to ESD.
2) Endoscopic diagnosis is impossible due to mucus and bleeding .
3) Histopathological diagnosis don't correspond endoscopic diagnosis.
4) Horizontal cut ends is not free of malignant tissue.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yao |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of Endoscopy
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino-city, Fukuoka, Japan
TEL
092-921-1011
yao@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Kojima |
Organization
Fukuoka University Chikushi Hospital
Division name
Department of gastroenterology
Zip code
818-8502
Address
1-1-1, Zokumyoin, Chikushino-city, Fukuoka, Japan
TEL
092-921-1011
Homepage URL
toshiki55imari@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University Chikushi Hospital
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Chikushi Hospital
Address
1-1-1, Zokumyoin, Chikushino-city, Fukuoka, Japan
Tel
092-921-1011
toshiki55imari@yahoo.co.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | 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
| 2017 | Year | 11 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 19 | Day |
Last modified on
| 2022 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036859
