UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014628 |
|---|---|
| Receipt number | R000017020 |
| Scientific Title | Multicenter randomized controlled study for delineating early gastric cancer by magnifying endoscopy with narrow-band imaging (M-NBI) |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2020/01/26 17:03:45 |
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Basic information
Public title
Multicenter randomized controlled study for delineating early gastric cancer by magnifying endoscopy with narrow-band imaging (M-NBI)
Acronym
M-NBI delineation study
Scientific Title
Multicenter randomized controlled study for delineating early gastric cancer by magnifying endoscopy with narrow-band imaging (M-NBI)
Scientific Title:Acronym
M-NBI delineation study
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison between success rates of conventional endoscopy plus chromoendoscopy and conventional endoscopy plus magnifying endoscopy with NBI in delineating early gastric cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison between success rates of conventional endoscopy plus chromoendoscopy and conventional endoscopy plus magnifying endoscopy with NBI in delineating early gastric cancer.
Key secondary outcomes
It is intended to determine differences in limitations of conventional endoscopy plus chromoendoscopy and conventional endoscopy plus magnifying endoscopy with NBI in delineating early gastric cancer and to compare correct diagnosis rates of the two techiniques according to clinicopathological findings.
In addition, correct diagnosis rates will be compared according to the conditions with high- and low-confidence prediction.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
conventional endoscopy plus chromoendoscopy
Interventions/Control_2
conventional endoscopy plus narrow-band imaging with magnifying endoscopy
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
Candidate patients have to meet all the following inclusion criteria to participate in the study.
(a) Patients who are diagnosed as early gastric cancer of 10 mm and over in diameter
1) Histopathological investigation of the biopsy confirmed gastric cancer.
2) If the patient have multiple cancers, a lesion of the most oral side lesion should be included..
(b) The patients who will be scheduled for endoscopic or surgical resection in each facilitiy should be included.
(c) Patients should be 20 years-old and over.
Key exclusion criteria
(a) Patients who had undergone gastrectomy.
(b) Patients who have the high risk for bleeding.
(c) Patients who do1 not give Informed concent.
Target sample size
340
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 | Takashi |
| Middle name | |
| Last name | Nagahama |
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
nagahamagogo@gmail.com
Sponsor or person
Institute
Central Research Institute for Endoscopy, Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
The Japanese Gastroenterological Association
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
nagahamagogo@gmail.com
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
福岡大学筑紫病院内視鏡部（福岡県）、大阪府立成人病センター消化器内科（大阪府）、石川県立中央病院消化器内科（石川県）、大分赤十字病院消化器内科（大分県）、高知赤十字病院（高知県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 23 | Day |
Last modified on
| 2020 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017020
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/05/01 | データ固定用160428.xlsx |
