UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intraoperative evaluation of free flap blood flow during head and neck reconstruction surgery using indocyanine green near infrared angiography
Title of the study (Brief title)	Intraoperative evaluation of free flap blood flow during surgery using indocyanine green near infrared angiography
Region	Japan

Condition
Condition	Head and neck cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate flap blood flow during head and neck reconstruction surgery using indocyanine green near infrared angiography
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To confirm whole flap blood flow using indocyanine green near infrared angiography
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	0.1-0.3 mg/kg of indocyanine green at concentration of 5mg/mL is intravenously injected during head and neck reconstructive 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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who received head and neck reconstruction surgery with written informed consent
Key exclusion criteria	Patients who have allergy against indocyanine green or iodine, or who are (may be) pregnant, or whom a doctor considered not eligible
Target sample size	10

Research contact person
Name of lead principal investigator	Shigeyuki Murono
Organization	Kanazawa University
Division name	Otolaryngology-Head and Neck Surgery
Address	13-1 Takaramachi, Kanazawa, Ishikawa
TEL	076-265-2413
Email	murono@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Shigeyuki Murono
Organization	Kanazawa University
Division name	Otolaryngology-Head and Neck Surgery
Address	13-1 Takaramachi, Kanazawa, Ishikawa
TEL	076-265-2413
Homepage URL
Email	murono@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Otolaryngology-Head and Neck Surgery, 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	2015 Year 12 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 02 Month 04 Day
Anticipated trial start date	2014 Year 02 Month 04 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	2015 Year 12 Month 25 Day
Last modified on	2016 Year 05 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023515