UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green
Acronym	Thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green
Scientific Title	Clinical trial of thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green
Scientific Title:Acronym	Thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green
Region	Japan

Condition
Condition	Primary lung cancer Metastatic lung tumor Benign lung tumor Infectious lung tumor Segmentectomy due to passive reasons
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparative analysis of identification of segmental plane using infrared thoracoscopy with indocyanine green or inflation-deflation technique
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Coincidence ratio of identification of segmental plan between infrared thoracoscopy with indocyanine green and inflation-deflation technique
Key secondary outcomes	Identification ratio of segmental plane using infrared thoracoscopy with indocyanine green in all cases Identification ratio of segmental plane using infrared thoracoscopy with indocyanine green in cases of failure of inflation-deflation technique Safety of using indocyanine green

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Indocyanine green 0.5 mg/kg is injected into a peripheral vein.
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 over 20 years old in obtaining written informed consent. 2. Indication of diseases A. cT1aN0M0, stage IA primary lung cancer with peripheral located, the diameter of 2 cm or smaller, and securing enough surgical margin at least the same diameter of the tumor size (same condition of JCOG0802/WJOG4607L) B. Metastatic lung tumor C. Benign tumor D. Infectious nodule E. segmentectomy due to passive reasons (e.g. insufficient pulmonary function) 3. Patients with obtaining written informed consent
Key exclusion criteria	1. Patients with indocyanine green allergy 2. Patients with iodine allergy 3. Patients with liver cirrhosis (Child-Pugh grade B or worse) 4. Clinicians decide to exclude from this trial in some reasons.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Toshiki Middle name Last name Tanaka
Organization	Yamaguchi University Hospital
Division name	Department of Surgery and Clinical Science
Zip code	755-8505
Address	1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan
TEL	0836222261
Email	kaueda@yamaguchi-u.ac.jp

Public contact
Name of contact person	1st name Toshiki Middle name Last name Tanaka
Organization	Yamaguchi University Hospital
Division name	Department of Surgery and Clinical Science
Zip code	755-8505
Address	1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan
TEL	0836-22-2261
Homepage URL
Email	tanakat@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Hospital
Institute
Department

Funding Source
Organization	Yamaguchi University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Yamaguchi University Hospital
Address	1-1-1 Minami-kogushi, Ube, Yamaguchi 755-8505, Japan
Tel	0836-22-2428
Email	me223@yamaguchi-u.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	2017 Year 01 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
Date of IRB	2017 Year 04 Month 26 Day
Anticipated trial start date	2017 Year 01 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 08 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 12 Month 20 Day
Last modified on	2019 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028931