UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of Still and Moving Images in the Diagnosis of Gastric Lesions Using Magnifying Narrow-Band Imaging in a Multicenter Trial
Title of the study (Brief title)	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	Hisashi Doyama
Organization	Ishikawa Prefectural Central Hospital
Division name	Department of Gastroenterology
Address	Kuratsukihigashi 2-1, Kanazawa city, Ishikawa Prefecture
TEL	076-237-8211
Email	doyama.134@ipch.jp

Public contact
Name of contact person	Tomoyuki Hayashi
Organization	Ishikawa Prefectural Central Hospital
Division name	Department of Gastroenterology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 01 Day
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

Related information
URL releasing protocol	http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0100857
Publication of results	Published
URL releasing results	http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0100857
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).
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