UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical research for evaluation of organ blood flow by using the ICG fluorescence method during esophagus cancer operations.
Title of the study (Brief title)	Organ bloodflow evaluation by using the ICG fluorescence method
Region	Japan

Condition
Condition	esophagus cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate and analyze for blood flow in a gastric wall, gastric tube and the trachea by using ICG during esophagus cancer operations.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	enables the observation of blood flow in a gastric wall, gastric tube and the trachea by using ICG during esophagus cancer operations.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	indocyanine green 25mg by dissolving with injection solution and use 0.5cc (1.25mg) per time when conducting chest procedure and creating gastric tube.
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 Histologically proven esophagus cancer 2 Aged over 20 at the time of registration 3 Patients conducting surgical operation for esophagus cancer 4 Written IC
Key exclusion criteria	1 Previous history of ICG allergy 2 Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size	30

Research contact person
Name of lead principal investigator	Hiroyuki Kuwano
Organization	Gunma University Hospital
Division name	Integrative Center of General Surgery
Address	3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8224
Email	maksakai@gunma-u.ac.jp

Public contact
Name of contact person	Makoto Sakai
Organization	Gunma University Hospital
Division name	Integrative Center of General Surgery
Address	3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL	027-220-8224
Homepage URL
Email	maksakai@gunma-u.ac.jp

Sponsor
Institute	Gunma University Hospital
Institute
Department

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	群馬大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 24 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 02 Month 24 Day
Anticipated trial start date	2016 Year 03 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 03 Month 23 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024754