UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014681 |
|---|---|
| Receipt number | R000017038 |
| Scientific Title | Probed-based confocal laser endomicroscopy imaging versus magnifying narrow-band imaging for differential diagnosis of gastric small depressed lesions:a prospective study |
| Date of disclosure of the study information | 2014/07/28 |
| Last modified on | 2017/02/02 20:43:32 |
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Basic information
Public title
Probed-based confocal laser endomicroscopy imaging versus magnifying narrow-band imaging for differential diagnosis of gastric small depressed lesions:a prospective study
Acronym
Gastric SDLs study
Scientific Title
Probed-based confocal laser endomicroscopy imaging versus magnifying narrow-band imaging for differential diagnosis of gastric small depressed lesions:a prospective study
Scientific Title:Acronym
Gastric SDLs study
Region
| Japan |
Condition
Condition
gastric small depressed lesions
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of confocal laser endomicroscopy imaging and magnifying narrow-band imaging on the diagnosis of gastric small depressed lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
accuracy of diagnosis
Key secondary outcomes
finding of confocal laser endomicroscopy imaging
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Patients who have gastric depressed lesions undergo confocal laser endomicroscopy imaging and magnifying narrow-band imaging for diagnosis,then they will be histologically evaluated.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The case with gastric small depressed lesions in the patients who undergo esophagogastroduodenoscopy at the NTT Medical Centor Tokyo.
Key exclusion criteria
No other serious complications, and use of no medications that might interfere with obtaining a biopsy specimen.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nonaka Kouichi |
Organization
NTT Medical Centor Tokyo
Division name
Department of gastroenterology
Zip code
Address
5-9-22,Higashi-Gotanda,Shinagawa-ku,Tokyo
TEL
03-3448-6111
nonaka513@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nonaka Kouichi |
Organization
NTT Medical Centor Tokyo
Division name
Department of gastroenterology
Zip code
Address
5-9-22,Higashi-Gotanda,Shinagawa-ku,Tokyo
TEL
03-3448-6111
Homepage URL
nonaka513@gmail.com
Sponsor or person
Institute
NTT Medical Centor Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
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
NTT東日本関東病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 28 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2017 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017038
