UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Indocyanine green (ICG) application to intraoperative navigation of fluorescence imaging
Title of the study (Brief title)	Intraoperative navigation with fluorescence imaging of indocyanine green (ICG)
Region	Japan

Condition
Condition	Gastrointestinal malignant tumor Ischemic bowel disease
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and efficacy of ICG fluorescence imaging for intraoperative identifyning the tumor localization.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Adverse event
Key secondary outcomes	Intraoperative visualization rate of lesion. Histopathological positive rate Pathological curative resection rate operative time, bleeding, intra and postoperative complication, recurrence rate Resected rate

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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	Indocyanine green (ICG)
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A patient who scheduled for treatment with surgery　by gstroenterological malignant tumor. A patient who need surgery due to acute intestinal ischemic bowel disease.
Key exclusion criteria	A patient who has a history of allergic reaction to the ICG. A patient who can not obtain the consent by document.
Target sample size	40

Research contact person
Name of lead principal investigator	Masafumi Inomata
Organization	Oita University
Division name	Gastrointestinal and pediatric surgery
Address	1-1Idaigaoka Hasamamachi Yufu city, Oita, Japan
TEL	097-586-5843
Email	geka1@oita-u.ac.jp

Public contact
Name of contact person	Yukio Iwashita
Organization	Oita University
Division name	Gastrointestinal and pediatric surgery
Address	1-1Idaigaoka Hasamamachi Yufu city, Oita, Japan
TEL	097-586-5843
Homepage URL	http://www.med.oita-u.ac.jp/surgery1/about/stuff/
Email	geka1@oita-u.ac.jp

Sponsor
Institute	Oita 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	None
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	大分大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 15 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 03 Month 15 Day
Anticipated trial start date	2016 Year 03 Month 15 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 04 Month 13 Day
Last modified on	2016 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025255