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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000696
Receipt No. 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

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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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000833

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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