UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036641 |
|---|---|
| Receipt number | R000041742 |
| Scientific Title | Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions |
| Date of disclosure of the study information | 2019/05/03 |
| Last modified on | 2019/11/08 12:18:24 |
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Basic information
Public title
Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Acronym
Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Scientific Title
Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Scientific Title:Acronym
Histologic diagnosis for EUS-guided fine needle aspiration using 22-gauge Acquire Needle in solid lesions
Region
| Japan |
Condition
Condition
solid lesion
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine histopathological diagnosis capability of EUS-FNA using a 22-gauge Acquire needle
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The diagnostic accuracy of histology
Key secondary outcomes
The number of passes for diagnosis
Adverse event
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 |
Interventions/Control_1
EUS-FNA is performed on solid tumors three times using a 22G acquire 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
Participants were patients with solid masses (>15mm) who were scheduled to undergo EUS-FNA.
Key exclusion criteria
Patients were excluded if they met any of the following criteria: (1) age < 20 years, (2) coagulopathy (international normalized ratio > 1.5 or platelet count < 50,000/mm ), (3) pregnant women, (4) GI obstruction, (5) a European Cooperative Oncology Group performance status of 4.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Iwashita |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu 501-1194
TEL
058-230-6308
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Uemura |
Organization
Gifu University Hospital
Division name
First Dept. of Internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu 501-1194
TEL
058-230-6308
Homepage URL
ueshin550621@gmail.com
Sponsor or person
Institute
Gifu University Hospital, First Dept. of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Hospital, First Dept. of Internal Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gifu Municipal Hospital
Tyunou Kousei Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Hospital Independent Ethics Committee
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
gjme00004@jim.gifu-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
岐阜大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 03 | 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
75
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
| 2017 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 11 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 03 | Day |
Last modified on
| 2019 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041742
| 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 |
