UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001710
Receipt number R000002043
Scientific Title Randomized trial of transbronchial biopsy using endobronchial ultrasonography with guide sheath (EBUS-GS) and navigation by virtual bronchoscopy or X-ray fluoroscopy for pulmonary peripheral lesions
Date of disclosure of the study information 2009/02/16
Last modified on 2018/02/09 13:07:57

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Basic information

Public title

Randomized trial of transbronchial biopsy using endobronchial ultrasonography with guide sheath (EBUS-GS) and navigation by virtual bronchoscopy or X-ray fluoroscopy for pulmonary peripheral lesions

Acronym

Randomized trial of transbronchial biopsy using EBUS-GS and VBN or X-ray fluoroscopy for pulmonary peripheral lesions

Scientific Title

Randomized trial of transbronchial biopsy using endobronchial ultrasonography with guide sheath (EBUS-GS) and navigation by virtual bronchoscopy or X-ray fluoroscopy for pulmonary peripheral lesions

Scientific Title:Acronym

Randomized trial of transbronchial biopsy using EBUS-GS and VBN or X-ray fluoroscopy for pulmonary peripheral lesions

Region

Japan


Condition

Condition

peripheral pulmonary lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To show that VBN can be applied instead of X-ray fluoroscopy in transbronchial biopsy using EBUS/GS for pulmonary peripheral lesions

Basic objectives2

Bio-equivalence

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

Yield (Diagnostic rate)

Key secondary outcomes

1)The time to reach the lesion
2)The time of first biopsy
3)The time of X-ray fluoroscopy
4)The time of total examination
5)Agreement between bronchi by virtual bronchoscopy and actual bronchi
6)Bronchial generation inserted by bronchoscopy
7)Bronchial generation observed by bronchoscopy
8)Complication
9)Pain degree subscale


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

With navigation by virtual bronchoscopy

Interventions/Control_2

With X-ray fluoroscopy

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.Peripheral pulmonary lesions of 30 mm> deemed, but not determined, as lung cancer
2.Not visible by bronchoscopy
3.20 or more than 20 years of age
4.SpO2 90% or more than 90%
5.Written informed consent

Key exclusion criteria

1.Visible by bronchoscopy
2.GGO
3.Lesions deemed as benign diseases on chest CT
4.Severe complication
5.Disability of cessation of anticoagulant or antiplatelet more than 2 days
6.Pregnancy

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Fumihiro Asano

Organization

Gifu Prefectural General Medical Center

Division name

Department of Pulmonary Medicine

Zip code


Address

4-6-1 Noishiki, Gifu, 500-8717,Japan

TEL

058-246-1111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Fumihiro Asano

Organization

Gifu Prefectural General Medical Center

Division name

Department of Pulmonary Medicine

Zip code


Address

4-6-1 Noishiki, Gifu, 500-8717,Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Department of Pulmonary Medicine, Gifu Prefectural General Medical Center

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2009 Year 02 Month 16 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2008 Year 11 Month 27 Day

Date of IRB


Anticipated trial start date

2009 Year 02 Month 01 Day

Last follow-up date

2011 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 02 Month 14 Day

Last modified on

2018 Year 02 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002043


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name