UMIN-CTR Clinical Trial

Public title

A feasibility study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of mediastinal nodal metastasis of lung cancer

Acronym

EBUS-TBNA in N2-diagnosis of lung cancer

Scientific Title

A feasibility study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of mediastinal nodal metastasis of lung cancer

Scientific Title:Acronym

EBUS-TBNA in N2-diagnosis of lung cancer

Region

Japan

Condition

Lung cancer

Classification by specialty

Pneumology

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess feasibility of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of medaistinal nodal metastasis of lung cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Sensitivity of EBUS-TBNA in the diagnosis of mediastinal nodal metastasis

Key secondary outcomes

Safety profile of EBUS-TBNA, Sensitivity and specificity of positron emission tomography (PET) in the diagnosis of mediastinal nodal metastasis

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

EBUS-TBNA is performed in lung cancer patients with suspicion of mediastinal nodal metastasis on chest CT

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1, Resectable and previously untreated non-small cell lung cancer with clinical stage T1-3N0M0
2, Mediastinal nodal enlargement on chest CT (long-axis diameter is 3cm or shorter and enlarger mediastinal nodal station is one or two)
3, PS, 0-2
4, Good major organ function
5, Written informed consent

Key exclusion criteria

1, Active infection
2, Any other active malignant tumor

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Seiki Hasegawa

Organization

Hyogo College of Medicine

Division name

Thoracic surgery

Zip code

Address

Mukogawa 1-1, Nishinomiya-city, Hyogo-prefacture, Japan

TEL

0798-45-6885

Email

ftanaka@med.uoeh-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Fumihiro Tanaka

Organization

Hyogo College of Medicine

Division name

Thoracic surgery

Zip code

Address

Mukogawa 1-1, Nishinomiya-city, Hyogo-prefacture, Japan

TEL

0798-45-6885

Homepage URL

http://www.jmto.org/trial/index.html

Email

ftanaka@hyo-med.ac.jp

Institute

Japan-multinational Trial Organization (JMTO)

Institute

Department

Personal name

Organization

Japan-multinational Trial Organization (JMTO)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

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

2008

Year

07

Month

31

Day

URL releasing protocol

http://www.jmto.org/index.html

Publication of results

Published

URL related to results and publications

https://www.karger.com/Article/FullText/447989

Number of participants that the trial has enrolled

Results

EBUS-TBNA is a standard procedure for pathological evaluation of mediastinal nodal (N2) status of lung cancer, but its feasibility in potentially operable patients with suspicion of minimal N2 remains unestablished. A prospective multicenter study was conducted to assess the feasibility. Clinical stage-IIIA-N2 non-small cell lung cancer (NSCLC) patients with mediastinal nodal enlargement on CT were eligible; patients were ineligible when CT revealed bulky station N2. When EBUS-TBNA revealed negative results, surgical staging procedures were mandatory. Among 20 eligible patients, EBUS-TBNA provided pathological confirmation of N2 (true-positive) in 12 patients. Among 8 patients with negative results with EBUS-TBNA, 4 patients were pathologically diagnosed of N2 disease with surgical staging procedures (false-negative), and 4 were finally diagnosed of non-N2 disease with nodal dissection by thoracotomy (true-negative). As a result, the sensitivity of EBUS-TBNA for N2 evaluation, the primary endpoint, was 75.0%. There documented no Grade 3-5 adverse event.EBUS-TBNA is safe and useful in pathological evaluation of N2 status even in potentially operable NSCLC patients with suspicion of minimal N2 on preoperative CT.

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

2008

Year

02

Month

14

Day

Date of IRB

Anticipated trial start date

2008

Year

07

Month

01

Day

Last follow-up date

2011

Year

02

Month

01

Day

Date of closure to data entry

2011

Year

02

Month

01

Day

Date trial data considered complete

2011

Year

02

Month

01

Day

Date analysis concluded

2011

Year

08

Month

01

Day

Other related information

Registered date

2008

Year

07

Month

31

Day

Last modified on

2019

Year

02

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001558

Single case data URL

Value
https://center6.umin.ac.jp/ice/1558