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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025333
Receipt No. R000028931
Scientific Title Clinical trial of thoracoscopic segmentectomy using infrared thoracoscopy with indocyanine green
Date of disclosure of the study information 2017/01/01
Last modified on 2019/06/23

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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 Open public recruiting
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 06 Month 23 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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