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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005757
Receipt No. R000006805
Scientific Title Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope
Date of disclosure of the study information 2011/06/11
Last modified on 2014/06/11

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Basic information
Public title Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope
Acronym Randomized study of EBUS-TBNA versus TEBUS-FNA
Scientific Title Randomized study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) versus transesophageal bronchoscopic ultrasound-guided fine needle aspiration (TEBUS-FNA) using an EBUS bronchoscope
Scientific Title:Acronym Randomized study of EBUS-TBNA versus TEBUS-FNA
Region
Japan

Condition
Condition Hilar/mediastinal lesions
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the tolerance, accuracy and safety of EBUS-TBNA versus TEBUS-FNA
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1. Patient comfort with EBUS-TBNA vs. TEBUS-FNA assessed by visual analog scale
Key secondary outcomes 1. Anxiety, satisfaction, coughing, vomiting, pain, dyspnea, willing to repeat procedure
2. Time of procedure
3. Diagnostic yield
4. Frequency of adverse effects
5. Oxygen desaturation
6. Doses of a sedative and an anesthetic

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-TBNA
Interventions/Control_2 TEBUS-FNA
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 lesions 10 mm or greater in short-axis diameter on CT adjoining both esophagus and trachea/bronchus, who need to undergo diagnostic bronchoscopy for the decision of management
2. 20 years old or more
3. Informed consent
Key exclusion criteria 1. Patients with lesions proven pathologically
2. Patients for mediastinal lymph node staging
3. Patients needing to undergo other bronchoscopic procedures (e.g. TBB, BAL, brushing)
4. Serious concomitant medical illness
5. Bleeding tendency
6. Pregnant woman
7. Other clinical difficulties in this study
Target sample size 110

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 masahideo@aol.com

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 国立病院機構名古屋医療センター (愛知県)

Other administrative information
Date of disclosure of the study information
2011 Year 06 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2011 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2013 Year 10 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
2011 Year 06 Month 10 Day
Last modified on
2014 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006805

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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