UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000696 |
|---|---|
| Receipt number | R000000833 |
| Scientific Title | Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) using 3.4-mm thin bronchoscope vs. EBUS with guide sheath (GS)-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions |
| Date of disclosure of the study information | 2007/04/30 |
| Last modified on | 2012/03/01 22:02:54 |
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Basic information
Public title
Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) using 3.4-mm thin bronchoscope vs. EBUS with guide sheath (GS)-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions
Acronym
Randomized study of EBUS-guided TBB using thin bronchoscope vs. EBUS-GS-guided TBB for diagnosis of peripheral pulmonary lesions
Scientific Title
Randomized study of endobronchial ultrasound (EBUS)-guided transbronchial biopsy (TBB) using 3.4-mm thin bronchoscope vs. EBUS with guide sheath (GS)-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions
Scientific Title:Acronym
Randomized study of EBUS-guided TBB using thin bronchoscope vs. EBUS-GS-guided TBB for 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
To compare the diagnostic accuracy of EBUS-guided TBB using 3.4-mm thin bronchoscope and EBUS-GS-guided TBB using 4.0-mm bronchoscope for diagnosis of peripheral pulmonary lesions
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Diagnostic yield; according to lesion size, location, benign or malignant
Key secondary outcomes
1.Frequency of adverse effects 2.Level of bronchus reached 3.Visibility on EBUS 4.Direct visibility of lesions with bronchoscope 5.Time of procedure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
EBUS-guided TBB using 3.4-mm thin bronchoscope
Interventions/Control_2
EBUS-GS-guided TBB using 4.0-mm bronchoscope
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 mass who need to undergo diagnostic bronchoscopy 2. 20 years old and above 3. Informed consent
Key exclusion criteria
1. Case with serious concomitant medical illness 2. Central pulmonary lesions 3. Diffuse pulmonary lesions 4. Re-examination due to prior failure in this trial 5. Patients who need to undergo other bronchoscopic procedure (e.g. TBNA, BAL) 6. Bleeding tendency 7. Pregnant woman 8. Other clinical difficulties in this trial
Target sample size
260
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
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
| 2007 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://journals.lww.com/jto/Abstract/2012/03000/Randomized_Study_of_Endobronchial.11.aspx
Number of participants that the trial has enrolled
Results
Background: In endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB), techniques using a thin bronchoscope or a guide sheath have been proposed for accurate biopsy instrument re-insertion into the bronchial route indicated by a radial ultrasonic probe. The purpose of the present study was to compare the diagnostic yields of these techniques for peripheral pulmonary lesions.
Methods: Patients with suspected peripheral pulmonary lesions were included in this prospective, randomized, non-inferiority study and assigned to undergo EBUS-TBB under fluoroscopic guidance using a prototype 3.4-mm thin bronchoscope or a 4.0-mm bronchoscope with a guide sheath.
Results: A total of 205 patients were enrolled and randomized, of whom 203 patients (101, thin bronchoscopic method; 102, guide sheath method) were included in the analysis. Diagnostic histologic specimens were obtained in 65% (41% for benign and 75% for malignant lesions) of the thin bronchoscopy group and 62% (25% for benign and 71% for malignant lesions) of the guide sheath group. Diagnostic performance of the thin bronchoscopic method was confirmed to be non-inferior to the guide sheath method (difference in diagnostic yields, 3.6%; 90% confidence interval, -7.5 to 14.7%). Mean procedure time was significantly shorter in the thin bronchoscopy group than the guide sheath group (27 min vs. 33 min; p = 0.002). Complications including pneumothorax, moderate bleeding and pneumonia occurred in 5% and 2% in the respective groups.
Conclusions: The diagnostic yields of each method are similar. EBUS-TBB using the thin bronchoscope can be performed more simply and less expensively without a guide sheath, and seems more practical.
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
| 2007 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | 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
| 2007 | Year | 04 | Month | 27 | Day |
Last modified on
| 2012 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000833
