UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017618 |
|---|---|
| Receipt number | R000020418 |
| Scientific Title | Investigation of the duodenal lesions using endocytoscopy system |
| Date of disclosure of the study information | 2015/05/19 |
| Last modified on | 2018/10/11 15:17:57 |
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Basic information
Public title
Investigation of the duodenal lesions using endocytoscopy system
Acronym
Endocutoscopy system for duodenal lesions
Scientific Title
Investigation of the duodenal lesions using endocytoscopy system
Scientific Title:Acronym
Endocutoscopy system for duodenal lesions
Region
| Japan |
Condition
Condition
duodenal lesions
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We clarify the features of the surface cell morphology of both malignant and benign lesions of the duodenum using endocytoscopy system(GIF-Y0002).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Accurate diagnosis rate concerning to the benign or malignant of the endocytoscopic pictures
Key secondary outcomes
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
| Medicine | Device,equipment |
Interventions/Control_1
We spray methylene blue or toluidine blue inside the duodenum as vital staining.We contact the tip of the endocytoscope to the target mucosa.We confirm the histological diagnosis of the target lesion using biopsy specimen.
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
Patients who agree this study and have duodenal lesions.
Key exclusion criteria
Patients who have the history of side effect using methylene blue or toluidine blue.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Youichi Kumagai |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, Japan
TEL
049-228-3619
kuma7srg1@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Youichi Kumagai |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Department of Digestive tract and General Surgery
Zip code
Address
1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, Japan
TEL
049-228-3619
Homepage URL
kuma7srg1@gmail.com
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical Center, Saitama Medical University
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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 19 | 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
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
| 2014 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 11 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 11 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 19 | Day |
Last modified on
| 2018 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020418
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
