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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032599
Receipt No. 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 2020/05/18

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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
Email 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
Email nk1208@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
Email 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 No longer recruiting
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 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
2018 Year 05 Month 15 Day
Last modified on
2020 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036780

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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