UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030634 |
|---|---|
| Receipt number | R000034974 |
| Scientific Title | Histologic diagnosis of pancreatic masses using 22-gauge endoscopic ultrasound needles with and without franseen design :A multicenter randomized controlled trial |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/05/05 19:31:07 |
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Basic information
Public title
Histologic diagnosis of pancreatic masses using 22-gauge endoscopic ultrasound needles with and without franseen design :A multicenter randomized controlled trial
Acronym
A multicenter randomized controlled trial for Endoscopic ultrasound-guided fine needle aspiration
Scientific Title
Histologic diagnosis of pancreatic masses using 22-gauge endoscopic ultrasound needles with and without franseen design :A multicenter randomized controlled trial
Scientific Title:Acronym
A multicenter randomized controlled trial for Endoscopic ultrasound-guided fine needle aspiration
Region
| Japan |
Condition
Condition
pancreatic mass
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare histological diagnosis ability of 22-gauge standard needle and 22-gauge franseen needle in patients with pancreatic mass.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy for histrogical diagnosis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EUS-FNA using 22-gauge standard needle
Interventions/Control_2
EUS-FNA using 22-gauge franseen needle
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
# patients with pancreatic mass detected by imaging
# Performace status 1 or 2
# Case that need a histologic diagnosis for the choice of the therapeutic method
# Written informed consent
Key exclusion criteria
# Inability to perform EUS-FNA
# Case with the bleeding tendency
# Inability to perform endoscopy
# Inabiltity to depict pancreatic mass by EUS
# Serious failure of other organs
# Case judged to be inadequate for this study
Target sample size
520
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Kitano |
Organization
Wakayama medical university
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera Wakayama
TEL
073-447-2300
kitano@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Itonaga |
Organization
Wakayama medical university
Division name
Second Department of Internal Medicine
Zip code
Address
811-1 Kimiidera Wakayama
TEL
073-447-2300
Homepage URL
itonaga@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama medical university
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2018 | Year | 04 | Month | 01 | 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
| 2017 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2021 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 29 | Day |
Last modified on
| 2021 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034974
