UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of bronchoscopy in combination with endobronchial ultrasonography, ultrafast papanicolaou stain, and virtual bronchoscopic navigation
Title of the study (Brief title)	usefulness of triple combination device in bronchoscopy
Region	Japan

Condition
Condition	peripheral pulmonary nodule
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluation of usefullness of virtual bronchoscopy, EBUS-GS, ultrafast papanicolaou stain for diagnosis of peripheral pulmonary nodules
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	diagnostic yield
Key secondary outcomes	examination time, number of biopsy , complications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	endobronchial ultrasonography, ultrafast papanicolaou stain, and virtual bronchoscopic navigation
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	1)Peripheral nodule cases of 3 cm or less chest CT 2)Cases that can be pointed out that shadow on chest radiograph 3)Cases a direct visualization not endoscopically 4)Cases consent was obtained in writing to the person or family
Key exclusion criteria	1)Heart failure patients and severe arrhythmia 2)Severe cases respiratory failure, chronic respiratory failure cases 3)Cases are complicated by respiratory active infection 4)Cases of lidocaine allergy 5)Pneumothorax cases 6)Patients have a bleeding tendency 7)Cases can not be obtained the cooperation of the patient 8)Other cases principal investigator was deemed inappropriate as the object of the study
Target sample size	50

Research contact person
Name of lead principal investigator	Chikatoshi Sugimoto
Organization	National Hospital Organization Kinki-chuo Chest Medical Center
Division name	Internal Medicine
Address	Nagasone-cho 1180, Kita-ku, Sakai City Osaka 591-8555, Japan
TEL	072-252-3021
Email	toshiya1027@gmail.com

Public contact
Name of contact person	Toshiya Maekura
Organization	National Hospital Organization Kinki-chuo Chest Medical Center
Division name	Internal Medicine
Address	Nagasone-cho 1180, Kita-ku, Sakai City Osaka 591-8555, Japan
TEL	072-252-3021
Homepage URL
Email	toshiya1027@gmail.com

Sponsor
Institute	National Hospital Organization Kinki-chuo Chest Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kinki-chuo Chest Medical Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 06 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 12 Day
Anticipated trial start date	2014 Year 06 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://jtd.amegroups.com/article/view/14702
Results
Other related information

Management information
Registered date	2014 Year 06 Month 17 Day
Last modified on	2017 Year 08 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016640