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
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
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
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
