UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000026238
Receipt No. R000030101
Scientific Title The utility of indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy for lung tumor
Date of disclosure of the study information 2017/02/21
Last modified on 2019/08/26 (Ver. 5)

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Basic information
Public title The utility of indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy for lung tumor
Acronym Indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy
Scientific Title The utility of indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy for lung tumor
Scientific Title:Acronym Indocyanine green-guided video-assisted thoracoscopic pulmonary segmentectomy
Region
Japan

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

Objectives
Narrative objectives1 The objective of this study is identification of actual anatomical line for pulmonary segmentectomy. Indocyanin green(ICG) and Storz Professional Imaga Enhancement System(SPIES) will visualize the blood flow of pulmonary, and determine the actual anatomical line for segmentectomy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Identification of actual anatomical line for pulmonary segmentectomy
Key secondary outcomes Adverse event
operetion time
blood loss
duration of chest drainage

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 Device,equipment
Interventions/Control_1 ICG-guided pulmonary 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
85 years-old >=
Gender Male and Female
Key inclusion criteria Lung cancer
metastatic lung tumor
clinical stage IA
Perfomance status(ECOG) 0-1
Patients maintaing the finctions of main organs
Patients with written consent of regstration for this examination
Key exclusion criteria Patients with high risk for registration of this examination
Patients who has an allergy for ICG
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Hidetaka
Middle name
Last name Uramoto
Organization Kanazawa Medical University
Division name Thoracic Surgery
Zip code 920-0293
Address 1-1 Daigaku, Uchinada, Ishikawa, Japan
TEL 076-286-2211
Email hidetaka@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name Nozomu
Middle name
Last name Motono
Organization Kanazawa Medical University
Division name Thoracic Surgery
Zip code 920-0293
Address 1-1 Daigaku, Uchinada, Ishikawa, Japan
TEL 076-286-2211
Homepage URL
Email motono@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Department Thoracic Surgery
Institute
Department

Funding Source
Organization Kanazawa Medical University
Department 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 Institutional Review Boards of Kanazawa Medical University
Address 1-1 Daigaku, Uchinada, Ishikawa, Japan
Tel 0762862211
Email tiken@kanazawa-med.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 金沢医科大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 21 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 36
Results 
Lung segmentectomy NIR fluorescence imaging with ICG was performed in 36 patients. The identification of the target segmental line was possible in 34 (94%) of the 36 patients.
Results date posted
2019 Year 08 Month 26 Day
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
2017 Year 02 Month 18 Day
Date of IRB
2017 Year 02 Month 20 Day
Anticipated trial start date
2017 Year 03 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 21 Day
Last modified on
2019 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030101