UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008030
Receipt number R000009414
Scientific Title Comparison of negative-pressure method and capillary-phenomenon method in endobronchial ultrasound-guided transbronchial needle aspiration
Date of disclosure of the study information 2012/05/26
Last modified on 2017/05/30 12:26:49

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Basic information

Public title

Comparison of negative-pressure method and capillary-phenomenon method in endobronchial ultrasound-guided transbronchial needle aspiration

Acronym

Comparison of negative-pressure method and capillary-phenomenon method in EBUS

Scientific Title

Comparison of negative-pressure method and capillary-phenomenon method in endobronchial ultrasound-guided transbronchial needle aspiration

Scientific Title:Acronym

Comparison of negative-pressure method and capillary-phenomenon method in EBUS

Region

Japan


Condition

Condition

A condition that necessitates mediastinal lymph node biopsy/aspiration cytology due to lung cancer and other disorders

Classification by specialty

Pneumology Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of negative-pressure method and capillary-phenomenon method in subcarinal station#7 lymph node, which is generally abundant in blood flow

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy to obtain sufficient specimen for pathological examination

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

negative pressure method

Interventions/Control_2

capillary phenomenon method

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

those patients whose sub-carinal station#7 lymph node needs to be sampled for medical reasons and who agreed to participate in the study

Key exclusion criteria

those patients who are less than 20 years old or those who cannot judge whether he or she should participate in the study

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaaki Sato

Organization

Kyoto University Hospital

Division name

Department of Thoracic Surgery

Zip code


Address

54 Kawahara-chyo, Shyogoin, Sakyo-ku, Kyoto-city, Kyoto

TEL

075-751-3111

Email



Public contact

Name of contact person

1st name
Middle name
Last name Masaaki Sato

Organization

Kyoto University Hospital

Division name

Department of Thoracic Surgery

Zip code


Address

54 Kawahara-chyo, Shyogoin, Sakyo-ku, Kyoto-city, Kyoto

TEL

075-751-4975

Homepage URL

http://www.thoracic-kyoto-u.gr.jp/

Email

satomasa@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University Hospital

Institute

Department

Personal name



Funding Source

Organization

Kyoto University Hospital

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

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2012 Year 05 Month 26 Day


Related information

URL releasing protocol

http://www.thoracic-kyoto-u.gr.jp/

Publication of results

Unpublished


Result

URL related to results and publications

http://www.thoracic-kyoto-u.gr.jp/

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

2012 Year 05 Month 24 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 01 Day

Last follow-up date

2014 Year 03 Month 01 Day

Date of closure to data entry

2014 Year 03 Month 01 Day

Date trial data considered complete

2014 Year 04 Month 01 Day

Date analysis concluded

2014 Year 07 Month 01 Day


Other

Other related information



Management information

Registered date

2012 Year 05 Month 26 Day

Last modified on

2017 Year 05 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009414


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name