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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001072
Receipt No. R000001286
Scientific Title Randomized clinical study on diagnostic accuracy of magnified endoscopic examination with narrow band imaging (NBI) for small depressive lesion in the stomach
Date of disclosure of the study information 2008/03/15
Last modified on 2011/09/11

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Basic information
Public title Randomized clinical study on diagnostic accuracy of magnified endoscopic examination with narrow band imaging (NBI) for small depressive lesion in the stomach
Acronym NBI study for gastric small lesion
Scientific Title Randomized clinical study on diagnostic accuracy of magnified endoscopic examination with narrow band imaging (NBI) for small depressive lesion in the stomach
Scientific Title:Acronym NBI study for gastric small lesion
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To estimate the diagnostic accuracy of magnifying endoscopic examination with NBI system for small gastric depressive lesion
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Diagnostic accuracy
Key secondary outcomes (1)Diagnostic sensitivity
(2)Diagnostic specificity
(3)Time required for confirming the endoscopic diagnosis
(4)Added efficacy of magnified examination with NBI on conventional non-magnified examination without NBI
(5)Frequency of endoscopically inconclusive lesions

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 NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Magnified endoscopic examination with NBI system
Interventions/Control_2 Conventional non-magnified examination without NBI system
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 (a)Depressive undiagnosed lesion within 10mm in length without ulceration or erosion in the stomach
(b)Written informed consent
(3)20<=age
Key exclusion criteria (a)Pathologically diagnosed lesion
(b)The history of surgical gastric resection
(c)Severe concomitant disease
(d)User of anti-coagulant
(e)Any other inappropriate condition for participating this study estimated by physician
Target sample size 1100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Manabu Muto
Organization Graduate school of medicine,
Kyoto University
Division name Division of Gastroenterology and Hepatology
Zip code
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-4319
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasumasa Ezoe
Organization Graduate school of medicine, Kyoto University
Division name Department of multidisciplinary cancer treatment
Zip code
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL 075-751-4319
Homepage URL
Email yasuzoe@kuhp.kyoto-u.ac.jp

Sponsor
Institute Innovation of New Diagnositic Modarities and Research on their diagnostic accuracy
Institute
Department

Funding Source
Organization Ministry of Health and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2008 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/21856268
Number of participants that the trial has enrolled
Results
The diagnostic values for M-NBI and C-WLI were (median): accuracy, 90.4% and 64.8%; sensitivity, 60.0% and 40.0%; and specificity, 94.3% and 67.9%, respectively. The accuracy and specificity of M-NBI were greater than those of C-WLI ( P <.001); the difference in sensitivity was not significant (P=.34). Combination of M-NBI with C-WLI significantly enhanced performance, compared with C-WLI alone: accuracy increased from (median) 40.0% to 95.0%, P <.001; sensitivity increased from 67.9% to 96.8%, P <.001; and specificity increased from 64.8% to 96.6%, P <.001.
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
2008 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2010 Year 05 Month 01 Day
Date of closure to data entry
2010 Year 07 Month 01 Day
Date trial data considered complete
2010 Year 09 Month 01 Day
Date analysis concluded
2010 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 03 Month 10 Day
Last modified on
2011 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001286

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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