UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The experimental study of novel lung segmentectomy using vitamin B2 and photodynamic thoracoscopid system.
Title of the study (Brief title)	The experimental study of novel lung segmentectomy.
Region	Japan

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

Objectives
Narrative objectives1	To verify the efficacy and safety of novel lung segmentectomy using vitamin B2 and photodynamic diagnosis thoracoscopoic system.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety of Vitamin B2. Efficacy of novel lung segmentectomy. Assessment:After surgery immediately, 2 weeks, and three months.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	The lung segmentectomy using vitamin B2 and photodynamic diagnosis during thoracoscopic surgery.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	The operative candidates for lung cancer or metastatic lung tumor.
Key exclusion criteria	No indication of lung segmentectomy.
Target sample size	10

Research contact person
Name of lead principal investigator	Isao Matsumoto
Organization	Kanazawa University
Division name	Department of Thoracic Cardiovascular and General Surgery
Address	13-1 Takara-machi, Kanazawa-city, Ishikawa prefecture, Japan
TEL	076-265-2354
Email	isa-mat@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Munehisa Takata
Organization	Kanazawa University
Division name	Department of Thoracic Cardiovascular and General Surgery
Address	13-1 Takara-machi, Kanazawa-city, Ishikawa prefecture, Japan
TEL	076-265-2354
Homepage URL
Email	takatamunehisa0223@yahoo.co.jp

Sponsor
Institute	Kanazawa University Hospital
Institute
Department

Funding Source
Organization	Kanazawa University
Organization
Division
Category of Funding Organization	Self funding
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 02 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 25 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 29 Day
Last modified on	2017 Year 03 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024522