UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009448 |
|---|---|
| Receipt number | R000011101 |
| Scientific Title | Forward-viewing versus oblique-viewing echoendoscopes in the diagnosis of upper gastrointestinal submucosal tumors with EUS-guided fine needle aspiration |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2015/03/04 20:20:25 |
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Basic information
Public title
Forward-viewing versus oblique-viewing echoendoscopes in the diagnosis of upper gastrointestinal submucosal tumors with EUS-guided fine needle aspiration
Acronym
Forward-viewing versus oblique-viewing echoendoscopes in the diagnosis of upper gastrointestinal submucosal tumors with EUS-guided fine needle aspiration
Scientific Title
Forward-viewing versus oblique-viewing echoendoscopes in the diagnosis of upper gastrointestinal submucosal tumors with EUS-guided fine needle aspiration
Scientific Title:Acronym
Forward-viewing versus oblique-viewing echoendoscopes in the diagnosis of upper gastrointestinal submucosal tumors with EUS-guided fine needle aspiration
Region
| Japan |
Condition
Condition
upper gastrointestinal submucosal tumors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility and yield of EUS-FNA with forward-viewing and oblique-viewing echoendoscopes in the diagnosis of upper gastrointestinal submucosal tumors
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the diagnostic yield
Key secondary outcomes
To evaluate the diagnstic accuracy,the quality of the specimen and compications
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The same upper gastrointestinal submucosal tumor are underwent with forward-viewing echoendoscope,after that oblique-viewing echoendoscope
Interventions/Control_2
The same upper gastrointestinal submucosal tumor are underwent with oblique-viewing echoendoscope,after that forward-viewing echoendoscope
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 with upper gastrointestinal submucosal tumors in the size of more than 15mm.
Cases with written and oral informed consent are included.
Key exclusion criteria
Cases with severe complications are excluded.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
Address
65, Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan
TEL
052-741-2172
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ippei Matsuzaki |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
65, Tsurumai-Cho, Showa-Ku, Nagoya, Aichi, Japan
TEL
052-744-2172
Homepage URL
imatsu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Nagoya University Graduate School of Medicine
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | 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
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
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 03 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 03 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 03 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 30 | Day |
Last modified on
| 2015 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011101
