UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002883
Receipt number R000003518
Scientific Title Phase II study of transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the diagnosis of sarcoidosis
Date of disclosure of the study information 2009/12/12
Last modified on 2013/02/14 22:17:47

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Basic information

Public title

Phase II study of transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the diagnosis of sarcoidosis

Acronym

TEBUS-FNA in the diagnosis of sarcoidosis

Scientific Title

Phase II study of transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope in the diagnosis of sarcoidosis

Scientific Title:Acronym

TEBUS-FNA in the diagnosis of sarcoidosis

Region

Japan


Condition

Condition

Sarcoidosis

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the diagnostic accuracy, safety and feasibility on TEBUS-FNA using an EBUS bronchoscope in patients with suspected stage I/II sarcoidosis

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

1. Sensitivity of pathological diagnosis of sarcoidosis

Key secondary outcomes

1. Time of procedure
2. Sensitivity: according to lymph node location, cytology or histology, stage I or II
3. Frequency of adverse effects
4. Feasibility


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

TEBUS-FNA in the diagnosis of sarcoidosis

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with suspected stage I/II sarcoidosis based on clinicoradiological pictures who have hilar-mediastinal nodes 10 mm or greater in short-axis diameter on CT
2. 18 years or older
3. Informed consent

Key exclusion criteria

1. Serious concomitant medical illness
2. SPO2<90% with supplemental oxygen
3. Obvious bleeding tendency
4. Pregnancy
5. Other clinical difficulties in this study

Target sample size

33


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

masahideo@aol.com


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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

国立病院機構 名古屋医療センター(愛知県)


Other administrative information

Date of disclosure of the study information

2009 Year 12 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.karger.com/Article/FullText/345207

Number of participants that the trial has enrolled


Results

A total of 62 lymph nodes with the mean shortest diameter of 13.6 mm were examined. Of the 33 patients enrolled, 29 were given a final diagnosis of sarcoidosis. Four of the residual patients had other diseases (1 lung cancer, 1 tuberculosis, 2 non-specific lymphadenitis). Transesophageal bronchoscopic ultrasound-guided fine needle aspiration showed noncaseating epithelioid cell granulomas in 25 of 29 patients (86%; 95% confidence interval, 73%-100%) with the final diagnosis of sarcoidosis. No complications were observed.

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

2009 Year 11 Month 09 Day

Date of IRB


Anticipated trial start date

2010 Year 01 Month 01 Day

Last follow-up date

2013 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

2009 Year 12 Month 11 Day

Last modified on

2013 Year 02 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003518


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name