UMIN-CTR Clinical Trial

Public title

Randomized study of 21-gauge vs. 22-gauge endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) needles for sampling mediastinal and hilar lesions

Acronym

Comparison of 21-gauge vs. 22-gauge EBUS-TBNA needles

Scientific Title

Randomized study of 21-gauge vs. 22-gauge endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) needles for sampling mediastinal and hilar lesions

Scientific Title:Acronym

Comparison of 21-gauge vs. 22-gauge EBUS-TBNA needles

Region

Japan

Condition

Mediastinal or hilar lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To compare the yields of EBUS-TBNA using 21-gauge and 22-gauge needles for sampling mediastinal and hilar lesions

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

1. Yields for adequate histologic specimen retrieval

Key secondary outcomes

1. Yields for adequate cytologic specimen sampling
2. Diagnostic yields
3. Frequency of adverse effects

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

EBUS-TBNA using 21-gauge needle

Interventions/Control_2

EBUS-TBNA using 22-gauge needle

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with enlarged mediastinal and/or hilar lesions 10 mm or greater in short-axis diameter on CT requiring diagnostic bronchoscopy
2. 20 years old and above
3. Informed consent

Key exclusion criteria

1. Patients with severe concomitant medical illness
2. Patients who were enrolled in other EBUS-TBNA studies
3. Bleeding tendency
4. Pregnant woman
5. Other clinical difficulties in this study

Target sample size

60

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

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

Homepage URL

Email

Masahideo@aol.com

Institute

Nagoya Medical Center

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2007

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://journals.lww.com/bronchology/Abstract/2011/10000/Randomized_Study_of_21_gauge_Versus_22_gauge.4.aspx

Number of participants that the trial has enrolled

Results

Methods: Sixty patients with hilar/mediastinal lymphadenopathy or a tumor adjacent to the central airway were enrolled and randomized to undergo EBUS-TBNA using a 21- or 22-gauge needle. Each histologic specimen obtained by EBUS-TBNA on the initial two punctures of each patient (total 120 punctures) was blindly categorized by a pathologist as follows: I, diagnostic; II, nondiagnostic but adequate (e.g. lymphoid tissue); III, nondiagnostic and inadequate (e.g. clot); and IV, no specimens.

Results: The specimens obtained by the 21-gauge needle were interpreted as I in 35, II in 8, III in 15 and IV in 2. The specimens obtained by the 22-gauge needle were judged to be I in 34, II in 13, III in 7, and IV in 6. The sampling yield of adequate histologic specimens (I and II) obtained by the 21- and 22-gauge needles was 72% and 78% (p = 0.40), respectively. No complications were associated with the procedures.

Conclusions: Histologic specimens can be obtained with a high sampling yield by either of the needles. Our study found no difference in sampling yield between the two needles.

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

Recruitment status

Completed

Date of protocol fixation

2007

Year

08

Month

21

Day

Date of IRB

Anticipated trial start date

2007

Year

09

Month

01

Day

Last follow-up date

2009

Year

03

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2007

Year

10

Month

01

Day

Last modified on

2011

Year

11

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001008