UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036780