UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral lesions
Title of the study (Brief title)	Usefulness of a navigation system "Directpath" in bronchoscopy for pulmonary peripheral 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 evaluate the usefulness of the navigation system Directpath in bronchoscopy for pulmonary peripheral lesions.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnostic yield
Key secondary outcomes	Directpath The bronchial generation order allowing automatic virtual image production The bronchial generation order for which manual registration is added Bronchoscope Consistency with virtual images The bronchial generation order allowing insertion and the outer diameter of the bronchus on virtual images The distance from the bronchoscope insertion site to the lesion and the number of bronchial divisions The bronchial generation order allowing observation The bronchial generation order allowing observation Diagnostic yield Diagnostic yields according to the method and bronchoscope used Diagnostic yield according to the lesion size Diagnostic yields according to the distance between the lesion and hilum Diagnosis yields according to the lesion visualization rate using ultrasound, whether the lesion is visualized, and the positional relationship between the ultrasound probe and lesion Visibility on EBUS. Diagnostic yield according to location of probe in relation to target lesion Examination time Safety, Complications

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Virtual images toward pulmonary peripheral lesions are produced using Directpath. Transbronchial biopsy (TBB) with virtual bronchoscopic navigation (VBN) is performed using a 2.8-mm ultrathin bronchoscope (BF-XP260F; channel inner diameter, 1.2 mm; Olympus). Subsequently, endobronchial ultrasound-guided transbronchial biopsy (EBUS-TBB) /transbronchial needle aspiration (TBNA) with VBN is performed using a 4.0-mm bronchoscope (BF-P260F, inner diameter of the operation channel, 2.0 mm; Olympus).
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. On chest CT images, an abnormal shadow is present in the peripheral area of the lung field, and bronchoscopy is necessary to make a diagnosis or determine treatment principles 2. 20 years of age or older 3. Consent in writing to participate in this study has been obtained from patients themselves
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. Case with pure ground glass opacity 6. Patients needing to undergo other bronchoscopic procedures (e.g. TBNA, BAL) 7. Bleeding tendency 8. Pregnant woman 9. Other clinical difficulties in this trial
Target sample size	30

Research contact person
Name of lead principal investigator	Fumihiro Asano
Organization	Gifu Prefectural General Medical Center
Division name	Department of Pulmonary Medicine and Bronchoscopy
Address	4-6-1, Noishiki, Gifu, Japan
TEL	058-246-1111
Email

Public contact
Name of contact person	Akifumi Tsuzuku
Organization	Gifu Prefectural General Medical Center
Division name	Department of Pulmonary Medicine and Bronchoscopy
Address	4-6-1, Noishiki, Gifu, Japan
TEL	058-246-1111
Homepage URL
Email	a.tsuzuku@gmail.com

Sponsor
Institute	Gifu Prefectural General 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)

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	岐阜県総合医療センター（岐阜県）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 23 Day
Anticipated trial start date	2013 Year 05 Month 23 Day
Last follow-up date	2013 Year 11 Month 30 Day
Date of closure to data entry	2013 Year 12 Month 31 Day
Date trial data considered complete	2013 Year 12 Month 31 Day
Date analysis concluded	2014 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 05 Month 23 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012607