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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008695
Receipt No. R000008970
Scientific Title A prospective randomized comparative study of endoscopic ultrasound-guided fine-needle aspiration between with and without the needle stylet using with the 22 gauge fine-needle aspiration needle
Date of disclosure of the study information 2012/08/15
Last modified on 2014/05/21

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Basic information
Public title A prospective randomized comparative study of endoscopic ultrasound-guided fine-needle aspiration between with and without the needle stylet using with the 22 gauge fine-needle aspiration needle
Acronym Comparative study of EUS-FNA with and without stylet
Scientific Title A prospective randomized comparative study of endoscopic ultrasound-guided fine-needle aspiration between with and without the needle stylet using with the 22 gauge fine-needle aspiration needle
Scientific Title:Acronym Comparative study of EUS-FNA with and without stylet
Region
Japan

Condition
Condition Solid lision detected by imaging study needs EUS-FNA from stomach or duodenum
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the existence of histologically determinable specimen, quality, diagnosis of the specimen about benignancy or malignancy between EUS-FNA with and without stylet
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Existance of histologically determinable target tissue
Key secondary outcomes The quality of the specimen, diagnosis of the specimen about benignancy or malignancy, puncture site and complication

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
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 Maneuver
Interventions/Control_1 Puncture without stylet
Interventions/Control_2 Puncture with stylet
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 Solid tunor detected by imaging study
Key exclusion criteria <20 years old
Enforcement of EUS-FNA is inappropriate
Target sample size 167

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kawakami
Organization Hokkaido University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kita 14, Nishi-5,Kita-ku, Sapporo, Japan
TEL 011-716-1161
Email hiropon@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Midori Nishioka
Organization Hokkaido University Hospital
Division name Clinical trial center
Zip code
Address Kita 14, Nishi-5,Kita-ku, Sapporo, Japan
TEL 011-716-1161
Homepage URL
Email midorin@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
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 08 Month 15 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
2012 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2012 Year 12 Month 18 Day
Date of closure to data entry
2012 Year 12 Month 18 Day
Date trial data considered complete
2012 Year 12 Month 18 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 08 Month 15 Day
Last modified on
2014 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008970

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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