UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy
Title of the study (Brief title)	Near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy
Region	Japan

Condition
Condition	Malignant pulumonary nodule
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To validate the safety of near-infrared fluorescence guided pulmonary segmentectomy following transbronchial indocyanine green injection using navigational bronchoscopy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sice effect of transbronchial indocyanine green injection to evaluate the safety of this technique
Key secondary outcomes

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	Maneuver
Interventions/Control_1	Transbronchial indocyanine green injection using navigational bronchoscopy followed by intraoperative fluorescence imaging using a near-infrared fluroescence thoracoscopy
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. Patients eligible for pulmonary segmentectomy for pulmonary malignancy or suspected lesions 2. Tumor size with a diameter of 3cm or lower 3. 20 years old or older 4. ECOG performance status 0-1 5. No definitive organd dysfuntion 6. Written consent obtaiend for this study
Key exclusion criteria	1. Allergy for indocyanine green 2. Hypersensictivity against iodine 3. Interstitial pneumonia or pulmonary fibrosis 4. Poor pulmonary function 5. Cognitive impairment 6. Pregnancy or breast-feeding
Target sample size	20

Research contact person
Name of lead principal investigator	Ichiro Yoshino
Organization	Chiba University Hospital
Division name	General Thoracic Surgery
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	0432227171
Email	iyoshino@faculty.chiba-u.jp

Public contact
Name of contact person	Hironobu Wada
Organization	Chiba University Hospital
Division name	General Thoracic Surgery
Address	1-8-1, Inohana, Chuo-ku, Chiba
TEL	0432227171
Homepage URL
Email	Hironobu.Wada@chiba-u.jp

Sponsor
Institute	General Thoracic Surgery, Chiba University Hospital
Institute
Department

Funding Source
Organization	No funding source
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	2016 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 03 Day
Anticipated trial start date	2016 Year 09 Month 27 Day
Last follow-up date	2017 Year 04 Month 28 Day
Date of closure to data entry	2017 Year 06 Month 21 Day
Date trial data considered complete	2017 Year 06 Month 21 Day
Date analysis concluded	2017 Year 06 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Navigational bronchoscopy-guided endobronchial indocyanin injection followed by intraoperative near-infrared thoracoscopy was demonsrated to be feasible and safe. This technique was useful to determine intersegmental plains during pulmonary segmetectomy.
Other related information

Management information
Registered date	2016 Year 09 Month 08 Day
Last modified on	2018 Year 09 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027574