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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024467
Receipt No. R000028034
Scientific Title Evaluation of contrast-enhanced harmonic endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)of pancreatic tumor: a prospective single center study.
Date of disclosure of the study information 2016/10/19
Last modified on 2017/12/28

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Basic information
Public title Evaluation of contrast-enhanced harmonic endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)of pancreatic tumor: a prospective single center study.
Acronym Evaluation of contrast-enhanced harmonic endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)of pancreatic tumor
Scientific Title Evaluation of contrast-enhanced harmonic endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)of pancreatic tumor: a prospective single center study.
Scientific Title:Acronym Evaluation of contrast-enhanced harmonic endoscopic ultrasonography guided fine needle aspiration(EUS-FNA)of pancreatic tumor
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the efficancy of contrast enhanced harmonic EUS-FNA prospectively in diagnosimg pancreatic lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes accuracy
Key secondary outcomes appropriate sampling rate

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 contrast-enhanced harmonic 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
100 years-old >=
Gender Male and Female
Key inclusion criteria # pancreatic tumor cases with pancreatic mass requiring EUS-FNA
# Written informed consent
Key exclusion criteria # inability to perform endoscopy
# Performance status=4
# Failure of other organs
# inability to obtain informed consent
# allergy of contrast agent
Target sample size 82

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
Email 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
Email itonaga@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
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
2016 Year 10 Month 19 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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 05 Day
Last follow-up date
2018 Year 03 Month 30 Day
Date of closure to data entry
2018 Year 03 Month 30 Day
Date trial data considered complete
2018 Year 03 Month 30 Day
Date analysis concluded
2018 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 18 Day
Last modified on
2017 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028034

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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