UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008048 |
|---|---|
| Receipt number | R000009477 |
| Scientific Title | Assessment of Still and Moving Images in the Diagnosis of Gastric Lesions Using Magnifying Narrow-Band Imaging in a Multicenter Trial |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2016/09/22 00:29:09 |
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Basic information
Public title
Assessment of Still and Moving Images in the Diagnosis of Gastric Lesions Using Magnifying Narrow-Band Imaging in a Multicenter Trial
Acronym
NBI-SM Study
Scientific Title
Assessment of Still and Moving Images in the Diagnosis of Gastric Lesions Using Magnifying Narrow-Band Imaging in a Multicenter Trial
Scientific Title:Acronym
NBI-SM Study
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Magnifying narrow-band imaging (M-NBI) is a useful diagnostic tool for distinguishing between early gastric cancer and non-cancerous lesions. In a recent multicenter, randomized, controlled study, M-NBI including moving images was shown to be more accurate than white-light imaging for diagnosing depressed small gastric mucosal cancers. However, the efficacy of M-NBI with moving images for diagnosing gastric lesions is still uncertain. In this study, we compared the diagnostic accuracy of M-NBI with still images only with that of M-NBI with both still and moving images, and tried to identify the additional benefits of moving images in terms of diagnostic accuracy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
difference in the accuracy of diagnosis of cancerous versus non-cancerous lesions between the still image test and the moving image test
Key secondary outcomes
subgroup analysis of the characteristics of the participants, including whether or not they were board-certified by the Japan Gastroenterological Endoscopy Society, and their relative experience with the M-NBI procedure
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Each study participant was first tested using the still images only (still image test), and then tested a month later using both the still and moving images (moving image test).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
participating doctors will not be limited.
Key exclusion criteria
nothing.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Doyama |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
Kuratsukihigashi 2-1, Kanazawa city, Ishikawa Prefecture
TEL
076-237-8211
doyama.134@ipch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Hayashi |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
Kuratsukihigashi 2-1, Kanazawa city, Ishikawa Prefecture
TEL
076-237-8211
Homepage URL
hayasix0917@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Ishikawa Prefectural Central 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
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0100857
Publication of results
Published
Result
URL related to results and publications
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0100857
Number of participants that the trial has enrolled
Results
There was no significant difference in the rate of accurate diagnosis of cancerous versus non-cancerous lesions between the still image and the moving image tests (59.9% versus 61.4%). However, the diagnostic accuracy were significantly lower in the still image test than the moving image test in the subgroup of board-certified endoscopists (62.5% versus 66.5%, p=0.04), the subgroup of endoscopists who had experienced more than 200 M-NBI procedures (65.6% versus 68.9%, p<0.05), and the subgroup of endoscopists who had experienced more than 15 M-NBI procedures in the previous month (65.1% versus 69.3%, p=0.04).
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
| 2012 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
| 2012 | Year | 10 | Month | 29 | Day |
Date trial data considered complete
| 2012 | Year | 10 | Month | 29 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 28 | Day |
Last modified on
| 2016 | Year | 09 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009477
