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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005980
Receipt No. R000005410
Scientific Title The prospective cohort study of the evaluation of Endoscopic Ultrasound-guided Fine Needle Aspiration for pancreatic solid tumor
Date of disclosure of the study information 2011/07/15
Last modified on 2015/01/10

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Basic information
Public title The prospective cohort study of the evaluation of Endoscopic Ultrasound-guided Fine Needle Aspiration for pancreatic solid tumor
Acronym Endoscopic Ultrasound-guided fine Needle aspiration Of Pancreatic Cancer Study (EUNOS-PC)
Scientific Title The prospective cohort study of the evaluation of Endoscopic Ultrasound-guided Fine Needle Aspiration for pancreatic solid tumor
Scientific Title:Acronym Endoscopic Ultrasound-guided fine Needle aspiration Of Pancreatic Cancer Study (EUNOS-PC)
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is the evaluation of the efficacy and safety of EUS-FNA for pancreatic solid tumors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The sensitivity of EUS-FNA for pancreatic solid tumors
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 EUS-FNA
Interventions/Control_2
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 solid tumors
# Patients who understand the aim of this study
# Patients who had not undergone EUS-FNA yet
# Japanese
Key exclusion criteria # Patients who have tendency of bleeding
# The lesion cannot be demonstrated
# Patients who have the high risk of complication by EUS-FNA
# There are some definite vessels between EUS and lesions
# The movement by breathing may cause puncture of another organs
# Patients with pancreatic cystic lesions
# Patients who don't understand the aim of this study
# EUS-FNA doesn't help to decide the treatment
Target sample size 230

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigetaka Yoshinaga
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Email shiyoshi@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigetaka Yoshinaga
Organization National Cancer Center Hospital
Division name Endoscopy Division
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email shiyoshi@ncc.go.jp

Sponsor
Institute Clinical application of the new technology for endoscopic diagnosis and researches on the improvement of the diagnostic accuracy
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Third Research Project on General Strategy Against Cancer
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 国立がん研究センター中央病院(東京都)、東京医科大学病院(東京都)、福島県立医科大学附属病院(福島県)、愛知県がんセンター中央病院(愛知県)、岐阜大学医学部附属病院(岐阜県)

Other administrative information
Date of disclosure of the study information
2011 Year 07 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
2010 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 09 Day
Last follow-up date
2014 Year 12 Month 26 Day
Date of closure to data entry
2015 Year 01 Month 10 Day
Date trial data considered complete
2015 Year 01 Month 10 Day
Date analysis concluded

Other
Other related information We evaluate efficacy and complications of EUS-FNA for pancreatic solid tumors.
We observe about patients&#39; condition 1 week after EUS-FNA.

Management information
Registered date
2011 Year 07 Month 15 Day
Last modified on
2015 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005410

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2015/01/10 150110EUNOS生データ_デポジトリ用.xlsx


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