UMIN-CTR Clinical Trial

Basic information
Public title	Precise anatomical lung segmentectomy by using near-infrared thoracoscopy (photodynamic eye) and transbronchial ICG instillation
Acronym	Lung segmentectomy by ICG fluorescence
Scientific Title	Precise anatomical lung segmentectomy by using near-infrared thoracoscopy (photodynamic eye) and transbronchial ICG instillation
Scientific Title:Acronym	Lung segmentectomy by ICG fluorescence
Region	Japan

Condition
Condition	lung tumor
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to make a clear boundary line , to obtain enough margin, and to perform pricese anatomycal segmentectomy by using transbronshial instillation of ICG.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	1. To confirm pricise anatomical segmentectomy by no ICG remaining in the residual lung and by postoperative CT 2) To study for the efficucy of this method in terms of protective effect of local recurrence
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	Device,equipment
Interventions/Control_1	ICG segmentectomy
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	lung malignancies
Key exclusion criteria	iodin allergy
Target sample size	200

Research contact person
Name of lead principal investigator	1st name YASUO Middle name Last name SEKINE
Organization	Tokyo Womens Medical University Yachiyo Medical Center
Division name	Dept. of Thoracic Surgery
Zip code	276-8524
Address	477-96 Owada-Shinden, Yachiyo, Chiba 276-8524 Japan
TEL	047-450-6000
Email	sekine.yasuo@twmu.ac.jp

Public contact
Name of contact person	1st name YASUO Middle name Last name SEKINE
Organization	Tokyo Womens Medical University Yachiyo Medical Center
Division name	Dept. of Thoracic Surgery
Zip code	276-8524
Address	477-96 Owada-Shinden, Yachiyo, Chiba 276-8524 Japan
TEL	047-450-6000
Homepage URL
Email	sekine.yasuo@twmu.ac.jp

Sponsor
Institute	Tokyo Womens Medical University Yachiyo Medical Center
Institute
Department

Funding Source
Organization	Tokyo Womens Medical University Yachiyo Medical Center, Department of Thoracic Surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tokyo Women's Medical University
Address	8-1 Kawadacho, Shinjuku-ku, Tokyo
Tel	03-3353-8111
Email	ohta.megumi@twmu.ac.jp

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	2018 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	Preinitiation
Date of protocol fixation	2018 Year 03 Month 01 Day
Date of IRB	2018 Year 03 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 01 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2018 Year 02 Month 23 Day
Last modified on	2021 Year 08 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035909