UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000000696
Receipt number	R000000833
Scientific Title	Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) using 3.4-mm thin bronchoscope vs. EBUS with guide sheath (GS)-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions
Date of disclosure of the study information	2007/04/30
Last modified on	2012/03/01 22:02:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) using 3.4-mm thin bronchoscope vs. EBUS with guide sheath (GS)-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions

Acronym

Randomized study of EBUS-guided TBB using thin bronchoscope vs. EBUS-GS-guided TBB for diagnosis of peripheral pulmonary lesions

Scientific Title

Scientific Title:Acronym

Randomized study of EBUS-guided TBB using thin bronchoscope vs. EBUS-GS-guided TBB for diagnosis of peripheral pulmonary lesions

Region

Japan

Condition

Benign or malignant pulmonary lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To compare the diagnostic accuracy of EBUS-guided TBB using 3.4-mm thin bronchoscope and EBUS-GS-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Assessment

Primary outcomes

Diagnostic yield; according to lesion size, location, benign or malignant

Key secondary outcomes

1.Frequency of adverse effects 2.Level of bronchus reached 3.Visibility on EBUS 4.Direct visibility of lesions with bronchoscope 5.Time of procedure

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

Intervention

No. of arms

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

EBUS-guided TBB using 3.4-mm thin bronchoscope

Interventions/Control_2

EBUS-GS-guided TBB using 4.0-mm bronchoscope

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. Patients with a peripheral pulmonary nodule or mass who need to undergo diagnostic bronchoscopy 2. 20 years old and above 3. Informed consent

Key exclusion criteria

1. Case with serious concomitant medical illness 2. Central pulmonary lesions 3. Diffuse pulmonary lesions 4. Re-examination due to prior failure in this trial 5. Patients who need to undergo other bronchoscopic procedure (e.g. TBNA, BAL) 6. Bleeding tendency 7. Pregnant woman 8. Other clinical difficulties in this trial

Target sample size

260

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Masahide Oki

Organization

Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code

Address

4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan

TEL

052-951-1111

Email

Public contact

Name of contact person

1st name

Middle name

Last name Masahide Oki

Organization

Nagoya Medical Center

Division name

Department of Respiratory Medicine

Zip code

Address

4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan

TEL

052-951-1111

Homepage URL

Email

Sponsor or person

Institute

Nagoya Medical Center

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

2007 Year 04 Month 30 Day

Related information

URL releasing protocol

Publication of results

Published

Result

URL related to results and publications

http://journals.lww.com/jto/Abstract/2012/03000/Randomized_Study_of_Endobronchial.11.aspx

Number of participants that the trial has enrolled

Results

Background: In endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB), techniques using a thin bronchoscope or a guide sheath have been proposed for accurate biopsy instrument re-insertion into the bronchial route indicated by a radial ultrasonic probe. The purpose of the present study was to compare the diagnostic yields of these techniques for peripheral pulmonary lesions.
Methods: Patients with suspected peripheral pulmonary lesions were included in this prospective, randomized, non-inferiority study and assigned to undergo EBUS-TBB under fluoroscopic guidance using a prototype 3.4-mm thin bronchoscope or a 4.0-mm bronchoscope with a guide sheath.
Results: A total of 205 patients were enrolled and randomized, of whom 203 patients (101, thin bronchoscopic method; 102, guide sheath method) were included in the analysis. Diagnostic histologic specimens were obtained in 65% (41% for benign and 75% for malignant lesions) of the thin bronchoscopy group and 62% (25% for benign and 71% for malignant lesions) of the guide sheath group. Diagnostic performance of the thin bronchoscopic method was confirmed to be non-inferior to the guide sheath method (difference in diagnostic yields, 3.6%; 90% confidence interval, -7.5 to 14.7%). Mean procedure time was significantly shorter in the thin bronchoscopy group than the guide sheath group (27 min vs. 33 min; p = 0.002). Complications including pneumothorax, moderate bleeding and pneumonia occurred in 5% and 2% in the respective groups.
Conclusions: The diagnostic yields of each method are similar. EBUS-TBB using the thin bronchoscope can be performed more simply and less expensively without a guide sheath, and seems more practical.

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

2007 Year 03 Month 23 Day

Date of IRB

Anticipated trial start date

2007 Year 04 Month 01 Day

Last follow-up date

2010 Year 03 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

2007 Year 04 Month 27 Day

Last modified on

2012 Year 03 Month 01 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000833

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name