UMIN-CTR Clinical Trial

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

gastric cancer

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Gastroenterology, Ishikawa Prefectural Central Hospital

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2012

Year

06

Month

01

Day

URL releasing protocol

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0100857

Publication of results

Published

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

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 related 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