UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001072 |
|---|---|
| Receipt number | 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 10:16:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yasuzoe@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Innovation of New Diagnositic Modarities and Research on their diagnostic accuracy
Institute
Department
Personal name
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
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
Value
https://center6.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 |
