UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014149 |
|---|---|
| Receipt number | 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 18:32:06 |
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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
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
ynakai-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016478
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
