UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of Airway Measurements using Stereoscopic Bronchoscopy, Endobronchial Ultrasonography and Multi-Detector CT.
Acronym	Airway Measurements using Stereoscopic Bronchoscopy, EBUS and MDCT
Scientific Title	Comparison of Airway Measurements using Stereoscopic Bronchoscopy, Endobronchial Ultrasonography and Multi-Detector CT.
Scientific Title:Acronym	Airway Measurements using Stereoscopic Bronchoscopy, EBUS and MDCT
Region	Japan

Condition
Condition	air way disease
Classification by specialty	Medicine in general Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Endobronchial Ultrasonography (EBUS) and Stereoscopic Bronchoscopy can assess the endobronchial area and peri-bronchial structure revealing abnormal findings in the central airways via brochoscopy. These techniques can be used to assess the diameter and length of the affected airway. We then compared findings of the EBUS images and Stereoscopic Bronchoscopy with MDCT.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endobronchial Ultrasonography (EBUS) and Stereoscopic Bronchoscopy can assess the endobronchial area and peri-bronchial structure revealing abnormal findings in the central airways via brochoscopy. These techniques can be used to assess the diameter and length of the affected airway. We then compared findings of the EBUS images and Stereoscopic Bronchoscopy with MDCT.
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Consecutive patients with airway disease who visited our institution. Eligible patients met the following criteria: those with respiratory tract symptoms with limited life expectancy due to airway disease, those who gave written informed consent to participate in this study.
Key exclusion criteria	Patients were excluded from this study if dyspnea was too severe to obtain CT findings, unable to receive EBUS and bronchoscope due to excessive bleeding, and patients deemed as unfit to enter the study by physician.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seiichi.Nobuyama
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory and Infectious Diseases, Department of Internal Medicine,
Zip code
Address	Sugou 2-16-1, Miyamae-ku, Kawasaki City, Kanagawa
TEL	044-977-8111
Email	nobuyama@iuhw.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Seiichi.Nobuyama
Organization	St. Marianna University School of Medicine
Division name	Division of Respiratory and Infectious Diseases, Department of Internal Medicine,
Zip code
Address	Sugou 2-16-1, Miyamae-ku, Kawasaki City, Kanagawa
TEL	044-977-8111
Homepage URL
Email	nobuyama@zeus.eonet.ne.jp

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	none

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

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	聖マリアンナ医科大学付属病院

Other administrative information
Date of disclosure of the study information	2010 Year 10 Month 18 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	2009 Year 02 Month 18 Day
Date of IRB	2009 Year 01 Month 15 Day
Anticipated trial start date	2009 Year 02 Month 01 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 03 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

Other
Other related information	none

Management information
Registered date	2010 Year 10 Month 17 Day
Last modified on	2020 Year 03 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002530