UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007980 |
|---|---|
| Receipt number | R000009381 |
| Scientific Title | The usefulness of follow-up narrow band imaging with magnifying endoscopy after endoscopic submucosal dissection for early gastric cancer |
| Date of disclosure of the study information | 2012/05/17 |
| Last modified on | 2013/06/17 09:35:44 |
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Basic information
Public title
The usefulness of follow-up narrow band imaging with magnifying endoscopy after endoscopic submucosal dissection for early gastric cancer
Acronym
The usefulness of follow-up NBI with ME after ESD for early gastric cancer
Scientific Title
The usefulness of follow-up narrow band imaging with magnifying endoscopy after endoscopic submucosal dissection for early gastric cancer
Scientific Title:Acronym
The usefulness of follow-up NBI with ME after ESD for early gastric cancer
Region
| Asia(except Japan) |
Condition
Condition
EGC patients treated by endoscopic submucosal dissection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the usefulness of follow-up narrow band imaging with magnifying endoscopy (NBI-ME) compared with white light endoscopy (WLE) alone and NBI for the detection of synchronous or metachronous neoplastic lesion after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The detection rates of synchronous or metachronous neoplastic lesion after endoscopic submucosal dissection (ESD) for early gastric cancer (EGC).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
White light endoscopy
Interventions/Control_2
NBI
Interventions/Control_3
NBI-ME
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
EGC patients treated with ESD
Key exclusion criteria
Patients who do not agrere with study enrollment
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Su Jin Hong |
Organization
Soonchunhyang University College of Medicine
Division name
Digestive Disease Center, Department of Internal Medicine
Zip code
Address
1174 Jung-Dong, Wonmi-gu, Bucheon, Gyeonggi-do, 420-767, Korea
TEL
82-32-621-5087
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Soonchunhyang University College of Medicine
Division name
Digestive Disease Center, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Soonchunhyang University Research Fund
Institute
Department
Personal name
Funding Source
Organization
Soonchunhyang University Research Fund
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2012 | Year | 05 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 05 | Month | 17 | Day |
Last modified on
| 2013 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009381
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| Registered date | File name |
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| Registered date | File name |
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