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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000508
Receipt No. 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

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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
Institute Nagoya Medical Center
Institute
Department

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
URL(English) https://upload.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


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