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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023013
Receipt No. R000026497
Scientific Title A single-center prospective pilot study to estimate the optimal white biopsy specimen length in EUS-FNA with 22-gauge needles
Date of disclosure of the study information 2016/07/04
Last modified on 2019/09/30

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Basic information
Public title A single-center prospective pilot study to estimate the optimal white biopsy specimen length in EUS-FNA with 22-gauge needles
Acronym A single-center prospective pilot study to estimate the optimal white biopsy specimen length in EUS-FNA with 22-gauge needles
Scientific Title A single-center prospective pilot study to estimate the optimal white biopsy specimen length in EUS-FNA with 22-gauge needles
Scientific Title:Acronym A single-center prospective pilot study to estimate the optimal white biopsy specimen length in EUS-FNA with 22-gauge needles
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the optimal white biopsy specimen length required in the pathological diagnosis (cut-off value) using a stereoscopic microscope in EUS-FNA.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the optimal white biopsy specimen length (cut-off value) using a stereoscopic microscope in EUS-FNA
Key secondary outcomes Accuracy of new FNA needle
Yield of core specimen on histological analysis of new FNA needle
Complication rate of new FNA needle

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 Diagnosis
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 New 22-gauge FNA needle
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 1) Cases need histological or cytological diagnosis for treatment
2) Cases obtained written informed consent
Key exclusion criteria 1) Cases with high risk of puncturing cystic lesion
2) Cases with known bleeding disorders
3) Cases regarded by doctors as inappropriate for the enrollment for some reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Mitsuhiro
Middle name
Last name Kida
Organization Kitasato University school of medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL +81-42-778-8111
Email m-kida@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Kosuke
Middle name
Last name Okuwaki
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology
Zip code 252-0374
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
TEL +81-42-778-8111
Homepage URL
Email kokuwaki@kitasato-u.ac.jp

Sponsor
Institute Department of Gastroenterology Kitasato University School of Medicine
Institute
Department

Funding Source
Organization N/A
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 Ethics Committee of Kitasato University Hospital
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa 252-0374 Japan
Tel +81-42-778-7756
Email rinri@med.kitasato-u.ac.jp

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 07 Month 04 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 07 Month 04 Day
Date of IRB
2016 Year 07 Month 04 Day
Anticipated trial start date
2016 Year 07 Month 04 Day
Last follow-up date
2018 Year 06 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
2016 Year 07 Month 04 Day
Last modified on
2019 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026497

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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