UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030773 |
|---|---|
| Receipt number | R000035005 |
| Scientific Title | Evaluation of Optimal White Core Specimen Length Obtained by EUS-FNAB with 22-gauge Franseen Needle -A Single-Center Prospective Pilot Traial- |
| Date of disclosure of the study information | 2018/01/11 |
| Last modified on | 2020/06/17 06:07:37 |
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Basic information
Public title
Evaluation of Optimal White Core Specimen Length Obtained by EUS-FNAB with 22-gauge Franseen Needle
-A Single-Center Prospective Pilot Traial-
Acronym
Evaluation of Optimal Specimen Obtained by EUS-FNAB
Scientific Title
Evaluation of Optimal White Core Specimen Length Obtained by EUS-FNAB with 22-gauge Franseen Needle
-A Single-Center Prospective Pilot Traial-
Scientific Title:Acronym
Evaluation of Optimal Specimen Obtained by EUS-FNAB
Region
| Japan |
Condition
Condition
Subepitheliai lesions in the upper gastrointestinal tract
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate optimal white core specimen length (cut-off value) required for pathological diagnosis using a stereoscopic microscope in EUS-FNAB
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
optimal white biopsy specimen length (cut-off value)
Key secondary outcomes
diagnostic accuracy
tissue acquisition rate
adverse event rate
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
| Device,equipment | Maneuver |
Interventions/Control_1
22-gauge franseen needle
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
1) subepitelial lesions in upper gastrointestinal tract which are required EUS-FNAB
2) providing written informed consent, and
age =or >20
Key exclusion criteria
1) high risk of puncturing cystic part
2) bleeding disorders
3) patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kida |
Organization
Kitasato University school of medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
m-kida@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL
+81-42-778-8111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Kitasato University Institutional Review Board
Address
1-15-1, Kitasato Minami Sagamihara Kanagawa, Japan
Tel
81-42-778-8111
rinri@med.kitasato-u.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
北里大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 11 | 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
30
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
| 2018 | Year | 01 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 11 | Day |
Last modified on
| 2020 | 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=R000035005
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
