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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008120
Receipt No. R000009547
Scientific Title The evaluation of Endoscopic Ultrasound-Guided Fine-needle Aspiration Using newly designed 22G Aspiration Needle with side port. -The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G FNA needle with or without side port for Solid Pancreatic mass-
Date of disclosure of the study information 2012/07/01
Last modified on 2016/06/07

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Basic information
Public title The evaluation of Endoscopic Ultrasound-Guided Fine-needle Aspiration Using newly designed 22G Aspiration Needle with side port.
-The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G FNA needle with or without side port for Solid Pancreatic mass-
Acronym The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G Aspiration needle with or without side port for Solid Pancreatic mass.
Scientific Title The evaluation of Endoscopic Ultrasound-Guided Fine-needle Aspiration Using newly designed 22G Aspiration Needle with side port.
-The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G FNA needle with or without side port for Solid Pancreatic mass-
Scientific Title:Acronym The Prospective Randomized, Controlled Trial of EUS-FNA Using 22G Aspiration needle with or without side port for Solid Pancreatic mass.
Region
Japan

Condition
Condition solid pancreatic mass
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the accuracy of EUS-FNA using newly designed FNA needle with side port.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes accuracy rate
Key secondary outcomes complication rate
number of puncture
Quality of the specimen

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 With side port group
EUS-FNA using EZ shot 2 with side port (NA-230H-8022)
Interventions/Control_2 Without side port group
EUS-FNA using EZ shot 2 without side port (NA-220H-8022)
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) Patients who have pancreatic mass which is detected by EUS.
2) age>20
3) Patients who understand and are willing to give a written informed consent about participation
Key exclusion criteria 1) Patients with performance status 4.
2) Patients with ASA scores greater than or equal to 3.
3) Patients who receive anticoagulant agent.
4) Women suspected of being pregnant
5) Histologically confirmed by other methods.
6) Platelets is lower than 50,000/mm3.
7) INR PT (Prothrombin time) is higher than 1.5.
8) Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotoshi Ishiwatari
Organization Sapporo Medical University
Division name The 4th department of internal medicine
Zip code
Address Minami 1-jo, Nishi 16-chome, Chuoku, Sapporo, Hokkaido
TEL 011-611-2111
Email ishihiro@sapmed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michihiro no
Organization Sapporo Medical University
Division name The 4th department of internal medicine
Zip code
Address Minami 1-jo, Nishi 16-chome, Chuoku, Sapporo, Hokkaido
TEL 011-611-2111
Homepage URL
Email ishihiro@sapmed.ac.jp

Sponsor
Institute The 4th department of Internal Medicine, Sapporo Medical University.
Institute
Department

Funding Source
Organization The 4th department of Internal Medicine, Sapporo Medical University.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2012 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2012 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 06 Month 07 Day
Last modified on
2016 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009547

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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