UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000027375
Receipt number	R000031367
Scientific Title	Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration (cross-sectional study)
Date of disclosure of the study information	2018/01/22
Last modified on	2019/10/25 17:34:18

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Basic information

Public title

Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration (cross-sectional study)

Acronym

Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration

Scientific Title

Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration (cross-sectional study)

Scientific Title:Acronym

Identification of factor influencing detectability on endobronchial ultrasound-guided transbronchial needle aspiration

Region

Japan

Condition

Lung cancer, Sarcoidosis

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To determine the appropriate number of needle stroke movements per puncture in EBUS-TBNA.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

The detectability of lesions in three groups according to the number of the stroke movements: the low-number group (20 times), the moderate-number group (25 times), and the high-number group (30 times).

Key secondary outcomes

1)Correlation between the detectability and size of lesions
2)The detectability of lesions of lung cancer and sarcoidosis.
3)The detectability of non-necrotizing granulomas in TBLB and EBUS-TBNA.
4)The rate of contraflow of blood in the EBUS-TBNA procedures

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

all patients with histologically proven lung cancer or sarcoidosis who had previously undergone EBUS-TBNA at the University of Miyazaki Hospital between April 2014 and July 2016.

Key exclusion criteria

the patients rejected to use the data for the clinical study

Target sample size

128

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Hironobu Tsubouchi

Organization

Faculty of Medicine, University of Miyazaki

Division name

Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine

Zip code

Address

Kihara 5200, Kiyotake, Miyazaki

TEL

0985-85-2965

Email

hironobu_tsubouchi@med.miyazaki-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Hironobu Tsubouchi

Organization

Faculty of Medicine, University of Miyazaki

Division name

Division of Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine

Zip code

Address

Kihara 5200, Kiyotake, Miyazaki

TEL

0985-85-2965

Homepage URL

Email

hironobu_tsubouchi@med.miyazaki-u.ac.jp

Sponsor or person

Institute

University of Miyazaki

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

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2018 Year 01 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

128

Results

We reviewed the EBUS-TBNA data of sarcoidosis (n = 29) and lung cancer (n = 99) patients. Using the data of their 43 sarcoidosis and 139 lung cancer lymph nodes, we evaluated the correlation between the detectability of granulomatous lesions or malignant lesions and the number of needle-stroke movements.
The number of needle stroke may influence the detectability of granulomatous lesions in sarcoidosis due to blood contamination caused by the contraflow of blood.

Results date posted

2019 Year 10 Month 25 Day

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

2016 Year 09 Month 29 Day

Date of IRB

Anticipated trial start date

2016 Year 09 Month 29 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Study Design: Cross-sectional study.
Setting & Participants: Among subjects who had undergone EBUS-TBNA between April 2014 and July 2016.

Management information

Registered date

2017 Year 05 Month 17 Day

Last modified on

2019 Year 10 Month 25 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031367

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name