UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032599 |
|---|---|
| Receipt number | R000036780 |
| Scientific Title | An exploratory study of the efficacy of a large guide sheath in endobronchial ultrasonography (EBUS) for peripheral pulmonary lesions |
| Date of disclosure of the study information | 2018/08/22 |
| Last modified on | 2021/05/27 10:00:34 |
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Basic information
Public title
An exploratory study of the efficacy of a large guide sheath in endobronchial ultrasonography (EBUS) for peripheral pulmonary lesions
Acronym
The efficacy of a large guide sheath in EBUS for peripheral pulmonary lesions
Scientific Title
An exploratory study of the efficacy of a large guide sheath in endobronchial ultrasonography (EBUS) for peripheral pulmonary lesions
Scientific Title:Acronym
The efficacy of a large guide sheath in EBUS for peripheral pulmonary lesions
Region
| Japan |
Condition
Condition
peripheral pulmonary lesions
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify of the efficacy of large guide sheath in endobronchial ultrasonography for peripheral pulmonary lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
number of tumor cells
Key secondary outcomes
1) EBUS probe that is localized within or adjacent to the lesion
2) possibility of diagnosis
3) number of sample of tumor cells among all samples
4) size of sample
5) PD-L1 testing success
6) adverse event
7)In case of change to small GS, tumor size, tumor location, characteristics of tumor, CT bronchus sign
8) proportion of tumor cells in biopsy sample
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 |
Interventions/Control_1
use large guide sheath
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) patient who is 20 years old or more.
2) patient who needs to perform a bronchoscopy using EBUS-GS to diagnose peripheral lung lesion.
3) written informed consent is obtained
Key exclusion criteria
1) patients who have lesion directly observed under bronchoscopy.
2) patients who underwent re-biopsy during treatment of lung cancer.
3) patients whose lung lesion is thought to be benign
4)patients who cannot be performed bronchoscopy because of severe comorbidity.
5) patients who cannot quite antiplatelet or anticoagulant therapy.
6)pregnant women
7)patients not suitable for this study by physician
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tachihara |
| Middle name | |
| Last name | Motoko |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine,Department of Internal Medicine
Zip code
650-0017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
+81-78-382-5660
mt0318@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsurada |
| Middle name | |
| Last name | Naoko |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
650-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
+81-78-382-5660
Homepage URL
nk1208@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Kobe University
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
Institutional Review Board, Kobe University Hospital Clinical Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel
078-382-6669
kansatsu@med.kobe-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
| 2018 | Year | 08 | Month | 22 | 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
87
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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 15 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036780
