UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014059
Receipt number R000015657
Scientific Title Factors Related to Diagnostic Yield of Transbronchial Biopsy in Peripheral Pulmonary Lesions
Date of disclosure of the study information 2014/05/26
Last modified on 2018/05/31 12:48:12

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Basic information

Public title

Factors Related to Diagnostic Yield of Transbronchial Biopsy in Peripheral Pulmonary Lesions

Acronym

Factors Related to Diagnostic Yield of Transbronchial Biopsy in Peripheral Pulmonary Lesions

Scientific Title

Factors Related to Diagnostic Yield of Transbronchial Biopsy in Peripheral Pulmonary Lesions

Scientific Title:Acronym

Factors Related to Diagnostic Yield of Transbronchial Biopsy in Peripheral Pulmonary Lesions

Region

Japan


Condition

Condition

Peripheral pulmonary lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the indication of transbronchial biopsy using virtual bronchoscopic navigation combined with radial-type endobronchial ultrasonography and guide sheath in peripheral pulmonary lesions.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Diagnostic yeild of transbronchial biopsy

Key secondary outcomes

Correlation between diagnostic yield and findings of CT and FDG-PET (lesion diameter, location of lesion, CT findings, relationship between the lesions and the bronchial tree, bronchial generation of VBN, and SUVmax of FDG-PET).


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

1.Small malignant peripheral pulmonary lesions of 30 mm>=
2.Not visible by bronchoscopy
3.20 or more than 20 years of age
4.Patients who underwent both CT and FDG-PET
5.SpO2 90 or more than 90%
6.Written informed consent

Key exclusion criteria

1.Visible by bronchoscopy
2.Less than 20 years of age
3.Pregnancy
4.Severe complication

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukihiro Umeda

Organization

University of Fukui

Division name

Third Department of Internal Medicine

Zip code


Address

23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan

TEL

0776-61-3111

Email

umeda@u-fukui.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukihiro Umeda

Organization

University of Fukui

Division name

Third Department of Internal Medicine

Zip code


Address

23-3 Matsuokashimoaizuki, Eiheiji-cho, Fukui 910-1193 Japan

TEL

0776-61-3111

Homepage URL


Email

umeda@u-fukui.ac.jp


Sponsor or person

Institute

University of Fukui

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Fukui Red Cross Hospital

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

福井大学医学部附属病院(福井県),福井赤十字病院(福井県)


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 26 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


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

2014 Year 05 Month 25 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 26 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information

To clarify the indication of transbronchial biopsy using virtual bronchoscopic navigation combined with radial-type endobronchial ultrasonography and guide sheath in peripheral pulmonary lesions, correlation between diagnostic yield and findings of CT and FDG-PET (lesion diameter, location of lesion, CT findings, relationship between the lesions and the bronchial tree, bronchial generation of VBN, and SUVmax of FDG-PET) will be observed.


Management information

Registered date

2014 Year 05 Month 25 Day

Last modified on

2018 Year 05 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015657


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name