UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029004 |
|---|---|
| Receipt number | R000031819 |
| Scientific Title | Comparison of utility of biopsy needle in EBUS-TBNA |
| Date of disclosure of the study information | 2017/09/05 |
| Last modified on | 2020/09/09 00:02:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of utility of biopsy needle in EBUS-TBNA
Acronym
Comparison of utility of biopsy needle in EBUS-TBNA
Scientific Title
Comparison of utility of biopsy needle in EBUS-TBNA
Scientific Title:Acronym
Comparison of utility of biopsy needle in EBUS-TBNA
Region
| Japan |
Condition
Condition
Lung cancer, mediastinal/hilar lymph node swelling
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clear the diagnostic difference of the biopsy between conventional 22G needle and newly developed 25G needles (produced by Boston scientific, or Cook).
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Concordance of pathological findings
Key secondary outcomes
Rate of obtaining histological core, pathological area, quality of cytological samples (lymphocyte/bleeding score), rapid on site evaluation, diagnostic rate in each station
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who received EBUS-TBNA.
Key exclusion criteria
Patients judged inappropriate by the attending.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yoshino |
Organization
Chiba University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
iyoshino@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Sakairi |
Organization
Chiba University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
TEL
043-222-7171
Homepage URL
y_sakairi1@chiba-u.jp
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chiba University Graduate School 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
Ethics Review Committee, Chiba University Graduate School of Medicine
Address
1-8-1, Inohana, Chuo-ku, Chiba, Japan
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
| 2017 | Year | 09 | Month | 05 | 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
63
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical information related to the diagnosis of biopsy is collected by EBUS-TBNA using 25G needle manufactured by Boston Scientific Co., Ltd, and 25G ProCore needle manufactured by Cook Co., Ltd.
Biopsy results performed by 22G conventional needle for same lymph node, is a control of this study. Epidemiological verification is conducted by prospectively registered database, in terms of mediastinal/hilar nodal diagnosis due to difference in puncture needle.
Management information
Registered date
| 2017 | Year | 09 | Month | 05 | Day |
Last modified on
| 2020 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031819
