UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020668 |
|---|---|
| Receipt number | R000023852 |
| Scientific Title | A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2019/09/16 22:29:30 |
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Basic information
Public title
A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions
Acronym
A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions
Scientific Title
A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions
Scientific Title:Acronym
A prospective randomized cotrolled study comparing EUS sonopsy CY(R) and 22G biopsy needles for EUS-guided fine-needle aspiration of solid pancreatic mass lesions
Region
| Japan |
Condition
Condition
solid pancreatic mass lesions
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is evaluating the efficacy of EUS sonopsy CY(R) by comparing EUS sonopsy CY(R) with 22G EUS-FNA(Sonotip 22G(R))needle by Gerke's Cellularity score.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The tissue collection rate in each group.
Key secondary outcomes
The tissue collection rate based on the tumor size location and puncture route, the tissue collection rate of all session ,
the tissue diagnosis rate and adverse event in each group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
In EUS-FNA, 1st puncture using EUS sonopsy CY(R) and 2nd puncture using 22GEUSFNA needle(Sonotip 22G(R)).
Interventions/Control_2
In EUS-FNA, 1st puncture using 22GEUSFNA needle(Sonotip 22G(R)) and 2nd puncture using EUS sonopsy CY(R).
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
Patients with pancreatic mass who are refered to EUS-FNA
Key exclusion criteria
Patients with Performance status 4
Patients who have risk of bleeding,or patients with platelet count less than fifty thousand/mm2
Patients with antithrombotic agent 2 agent or more
Patients with pancreatic mass which we cannot detect by EUS
Pregnant woman
Patients less than 20 years old
Patients who do not agree to participate in this study
Patients who determined to be inappropriate
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hironari Kato |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Okayama, 700-8558, Japan
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho mizukawa |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-5-1 Shikata-cho, Okayama, 700-8558, Japan
TEL
086-235-7219
Homepage URL
mimizukawa@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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
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
| 2016 | Year | 01 | Month | 20 | 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
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023852
