UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017031 |
|---|---|
| Receipt number | R000019749 |
| Scientific Title | Diagnosability of wet suction FNA technique for gastrointenstinal submucosal tumor |
| Date of disclosure of the study information | 2015/04/08 |
| Last modified on | 2024/04/09 13:59:27 |
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Basic information
Public title
Diagnosability of wet suction FNA technique for gastrointenstinal submucosal tumor
Acronym
wet technique
Scientific Title
Diagnosability of wet suction FNA technique for gastrointenstinal submucosal tumor
Scientific Title:Acronym
wet technique
Region
| Japan |
Condition
Condition
gastrointenstinal submucosal tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
efficacy of wet suction FNA technique for gastrointenstinal submucosal tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A comparison between wet and dry suction FNA technique for gastrointenstinal submucosal tumor
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
first wet suction FNA technique, second dry suction FNA technique
Interventions/Control_2
first dry suction FNA technique, second wet suction FNA technique
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patient with gastrointestinal SMT of more than 10mm
2. agreement of patient
Key exclusion criteria
1. the one that I cannot discontinue or convert that followed guideline among patients taking antithrombotic drugs
2. reject of patient
3. patient that was judged to be inappropriate by a doctor
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Takuto |
| Middle name | |
| Last name | Hikichi |
Organization
Fukushima Medical University Hospital
Division name
Department of Endoscopy
Zip code
960-1247
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1586
takuto@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Waragai |
Organization
Division of Medicine, Fukushima Medical University School of Medicine
Division name
Department of Gastroenterology
Zip code
960-1247
Address
1 Hikarigaoka, Fukushima
TEL
024-547-1202
Homepage URL
yw3041@fmu.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Division of Medicine, Fukushima Medical University School of Medicine, and Department of Endoscopy, Fukushima Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Gastroenterology, Division of Medicine, Fukushima Medical University School of Medicine
Address
1 Hikarigaoka, Fukushima
Tel
024-547-1202
yw3041@fmu.ac.jp
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
| 2015 | Year | 04 | Month | 08 | 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
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019749
