UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006042 |
|---|---|
| Receipt number | R000007152 |
| Scientific Title | Prospective multicenter study of the effectiveness of NBI magnified endoscopy with acetic acid for the diagnosis of histological type of early gastric cancer. |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2016/01/25 21:59:37 |
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Basic information
Public title
Prospective multicenter study of the effectiveness of NBI magnified endoscopy with acetic acid for the diagnosis of histological type of early gastric cancer.
Acronym
Acetic acid NBI study
Scientific Title
Prospective multicenter study of the effectiveness of NBI magnified endoscopy with acetic acid for the diagnosis of histological type of early gastric cancer.
Scientific Title:Acronym
Acetic acid NBI study
Region
| Japan |
Condition
Condition
early gastric cancer, depressed type
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the accuracy of white light endoscopy, NBI magnified endoscopy and acetic acid NBI magnified endoscopy for the diagnosis of histological type of early gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy rate of the diagnosis of histological type
(White light endoscopy, NBI magnified endoscopy vs. acetic acid NBI magnified endoscopy)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who have an early gastric cancer treated by ESD (endoscopic submucosal dissection)
Key exclusion criteria
1. The patients who rejected informed consent.
2. The patients who were treated by chemotherapy or radiation therapy.
3. The patients without tolerability for prolonged sedation.
4. The diameter of lesion is more over 4cm in size.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | OYAMA TSUNEO |
Organization
Saku Central Hospital
Division name
Gastroenterology
Zip code
Address
197 Usuda, Saku-city, Nagano.
TEL
0267-82-3131
kishinotakaaki@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KISHINO TAKAAKI |
Organization
Saku Central Hospital
Division name
Gastroenterology
Zip code
Address
197 Usuda, Saku-city, Nagano.
TEL
0267-82-3131
Homepage URL
kishinotakaaki@hotmail.co.jp
Sponsor or person
Institute
Saku Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Saku Central Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2011 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Histological types of target areas were wel, mod and poor in 166, 40 and 15 cases, respectively. The sensitivity of wel, mod and poor by WL, NBI-ME and NBI-AA were 99.4% (165/166), 89.6% (149/166) and 94.6% (157/166) in wel, 0% (0/40), 20% (8/40) and 12.5% (5/40) in mod and 60% (9/15), 60% (9/15) and 60% (9/15) in poor, respectively. There were no significant differences. Sub-analysis: The diagnostic accuracy by surface pattern in NBI-ME was 100% (20/20) in pit pattern, 78.9% (120/152) in villous pattern and 53.1% (26/49) in unclear pattern. And NBI-AA changed these diagnostic accuracy 100% (20/20), 78.3% (119/152) and 65.3% (32/49) respectively. While the diagnostic accuracy by unclear pattern in NBI-ME was low compared to other surface patterns, NBI-AA improved it from 53.1% to 65.3%.
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
| 2011 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
We presented our research results at a conference. We are submitting our manuscript.
Management information
Registered date
| 2011 | Year | 07 | Month | 25 | Day |
Last modified on
| 2016 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007152
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
