UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Hirotoshi Ishiwatari
Organization	Sapporo Medical University
Division name	The 4th department of internal medicine
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	Michihiro no
Organization	Sapporo Medical University
Division name	The 4th department of internal medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000009547