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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010021
Receipt No. R000011518
Scientific Title A multicenter randomized controlled study comparing needles with and without side hole for EUS guided fine needle biopsy in diagnosis of pancreatic solid lesions.
Date of disclosure of the study information 2013/02/18
Last modified on 2017/02/10

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Basic information
Public title A multicenter randomized controlled study comparing needles with and without side hole for EUS guided fine needle biopsy in diagnosis of pancreatic solid lesions.
Acronym A study comparing diagnositic yields between EUS-FNA needles with and without side hole.
Scientific Title A multicenter randomized controlled study comparing needles with and without side hole for EUS guided fine needle biopsy in diagnosis of pancreatic solid lesions.
Scientific Title:Acronym A study comparing diagnositic yields between EUS-FNA needles with and without side hole.
Region
Japan

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

Objectives
Narrative objectives1 In diagnoses of pancreatic solid lesions by EUS-FNA, needles without and with side holes are compared in terms of efficacy and safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Primary endpoints: Rate of satisfactory sampling for histological diagnosis, diagnositic accuracy.
Secondary endpoints: rate of adverse events, technical success rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 EUS-FNA needle with side hole
Interventions/Control_2 EUS-FNA needle without side hole
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 Pancreatic solid lesions depicted by imaging modalities
ECOG performance status = 1, 2
No severe dysfunction in other organs Requirement of pathological diagnosis for patient treatment
Written informed consent obtained from patients
Key exclusion criteria Presence of intervening vessels or other organs on the puncture line
High riks of complications (bleeding, tumor seeding)
Inability to obtain informed consent
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Kitano
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Ken Kamata
Organization Kinki University Faculty of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address 377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL 072-366-0221
Homepage URL
Email

Sponsor
Institute Osaka EUS-FNA Study Group
Institute
Department

Funding Source
Organization Kinki University Faculty of Medicine
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
2013 Year 02 Month 18 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 Completed
Date of protocol fixation
2013 Year 02 Month 09 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 25 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 12 Day
Last modified on
2017 Year 02 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011518

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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