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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014149
Receipt No. R000016478
Scientific Title A prospective multicenter study of EUS-guided through-the-needle biopsy (EUS-TTNB) for abdominal solid lesion
Date of disclosure of the study information 2014/06/03
Last modified on 2017/05/31

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Basic information
Public title A prospective multicenter study of EUS-guided through-the-needle biopsy (EUS-TTNB) for abdominal solid lesion
Acronym EUS-TTNB
Scientific Title A prospective multicenter study of EUS-guided through-the-needle biopsy (EUS-TTNB) for abdominal solid lesion
Scientific Title:Acronym EUS-TTNB
Region
Japan

Condition
Condition Patients who will undergo EUS-FNA for an abdominal solid lesion
Classification by specialty
Hepato-biliary-pancreatic medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of EUS-TTNB
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diagnostic yield of malignancy (EUS-TTNB, EUS-FNA, EUS-TTNB+EUS-FNA)
Key secondary outcomes Technical success, safety, rate of macroscopic tissue sampling, the diagnostic yield of specific diseases

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 EUS-guided through-the-needle biopsy
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)Patients with abdominal solid lesion 15mm amd larger who will undergo EUS-FNA
2)Age 20 years and older
3)ECOG PS 0-3
4)written informed consent
Key exclusion criteria 1)Patients with coagulopathy
2)Patients whose lesions are not safely punctured by EUS-FNA
3)No informed consent
4)Patients who are considered as inappropriate for study enrollment by investigators
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization The University of Tokyo, Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku Tokyo
TEL 03-3815-5411
Email isayama-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yousuke Nakai
Organization The University of Tokyo, Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku Tokyo
TEL 03-3815-5411
Homepage URL
Email ynakai-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization None
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 東京大学医学部付属病院(東京都), 岐阜大学附属病院(岐阜県), 岐阜市民病院(岐阜県), 東京警察病院(東京都), 日本赤十字社医療センター(東京都), 関東中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 03 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 Terminated
Date of protocol fixation
2014 Year 05 Month 09 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 03 Day
Last modified on
2017 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016478

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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