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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008048
Receipt No. 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

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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
Email 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
Email hayasix0917@gmail.com

Sponsor
Institute Department of Gastroenterology, Ishikawa Prefectural Central Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009477

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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