UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Title of the study (Brief title)	Pre-operative bronchoscopic marking of small pulmonary lesions using virtual bronchoscopic navigation
Region	Japan

Condition
Condition	Pulmonary neoplasms
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To overcome the limitation of conventional CT-guided marking including complications (air emborisms, bleeding, pneumothorax) adn technical limitations (mainly due to anatomical localization of the target), by using 3D virtual bronchoscopic navigation, bronchoscopic marking is conducted and the efficacy and safety will be examined.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Safety of bronchoscopic marking 2) Accuracy of marking 3) Efficacy as an aid for lung resection
Key secondary outcomes	Outcome of lung resection (resection with free margin) in pathology

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	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Brpmchoscopically inject indigo carmine (0.5-1ml)to peripheral lung tissue
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	Patients who have small (=<2cm in diameter) peripheral lung nodules that are hardly palpable, or lesions with ground glass opacity (regardless of the size) for which pre-operative marking is considered to be necessary based on clinical judgement.
Key exclusion criteria	Those who have past or present medical history of asthma
Target sample size	40

Research contact person
Name of lead principal investigator	Kenji Suzuki
Organization	Juntendo University
Division name	Department of General Thoracic Surgery
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	kjsuzuki@juntendo.ac.jp

Public contact
Name of contact person	Kenji Suzuki
Organization	Juntendo University
Division name	Department of General Thoracic Surgery
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	kjsuzuki@juntendo.ac.jp

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Juntendo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	順天堂大学医学部附属順天堂医院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 29 Day
Anticipated trial start date	2013 Year 06 Month 02 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2018 Year 03 Month 31 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 03 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 29 Day
Last modified on	2018 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012689