UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000508
Receipt number R000000616
Scientific Title A phase II study of using a thin bronchoscope (XBF-3B40Y1) for the diagnosis of peripheral pulmonary lesions
Date of disclosure of the study information 2006/11/01
Last modified on 2008/12/08 20:49:32

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Basic information

Public title

A phase II study of using a thin bronchoscope (XBF-3B40Y1) for the diagnosis of peripheral pulmonary lesions

Acronym

Utility of thin bronchoscope for the diagnosis of peripheral pulmonary lesions

Scientific Title

A phase II study of using a thin bronchoscope (XBF-3B40Y1) for the diagnosis of peripheral pulmonary lesions

Scientific Title:Acronym

Utility of thin bronchoscope for the diagnosis of peripheral pulmonary lesions

Region

Japan


Condition

Condition

Benign or malignant pulmonary lesions

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate the utility of a novel thin bronchoscope (XBF-3B40Y1) for the diagnosis of peripheral pulmonary lesions.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Diagnostic yield

Key secondary outcomes

1. Frequency of adverse effects 2. Level of bronchus reached; comparison with standard bronchoscope 3. Optimal number of biopsies


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

1. Serious concomitant medical illness 2. Obvious central pulmonary lesion 3. Diffuse pulmonary lesions 4. Re-examination due to prior failure in this trial 5. Obvious bleeding tendency 6. Pregnancy 7. Other clinical difficulties in this study

Target sample size

170


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


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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2006 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://erj.ersjournals.com/cgi/content/full/32/2/465

Number of participants that the trial has enrolled


Results

A total of 118 patients were included in this prospective study. Endobronchial lesions were visualized with the standard bronchoscope in 16 patients, and the other 102 patients underwent biopsies with the thin bronchoscope. Four patients were lost to follow-up. Thus, a total of 98 patients with peripheral pulmonary lesions (median size, 30.5 mm) were included in the final analysis. The mean bronchus level reached with the standard bronchoscope and the thin bronchoscope was 2.3 and 4.3 generations, respectively. Endobronchial abnormality was revealed with the thin bronchoscope in a further 14 patients. Diagnostic material was obtained in 50 of 68 patients (74%) with malignant disease and 18 of 30 patients (60%) with benign disease. There were no major complications.

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

2005 Year 03 Month 23 Day

Date of IRB


Anticipated trial start date

2005 Year 03 Month 01 Day

Last follow-up date

2007 Year 03 Month 01 Day

Date of closure to data entry

2008 Year 12 Month 01 Day

Date trial data considered complete

2008 Year 12 Month 01 Day

Date analysis concluded

2008 Year 12 Month 01 Day


Other

Other related information

Observation of diagnostic yield of transbronchial biopsy using new thin bronchoscope for peripheral pulmonary lesions


Management information

Registered date

2006 Year 10 Month 30 Day

Last modified on

2008 Year 12 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name