UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory clinical study of lymphatic and blood flow evaluation by indocyanine-green fluorescence imaging in esophageal cancer operation
Title of the study (Brief title)	Exploratory clinical study of lymphatic and blood flow evaluation by indocyanine-green fluorescence imaging in esophageal cancer operation
Region	Japan

Condition
Condition	Esophageal cancer patient whose assigned to surgical treatment
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of lymphatic flow imaging on blood flow evaluation using indocyanine-green fluorescence imaging(IGFI) in esophageal cancer patients.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Visibility of the blood flow pattern after lymphatic imaging.
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	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	indocyanine green
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	Esophageal cancer patients whose assigned to surgical resection 1) 20yrs and older 2) PS(ECOG Performance status) 0 or 1 3) favorable major organ function
Key exclusion criteria	1) past history of ICG or Iodine hypersensitivity 2) pregnant patient 3) breast feeding patient
Target sample size	19

Research contact person
Name of lead principal investigator	Yasuyuki Seto
Organization	University of Tokyo Hospital
Division name	Gastrointestinal Surgery
Address	7-3-1, Bunkyo-ku Hongou, Tokyo
TEL	03-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
Name of contact person	Ryohei Iwata
Organization	University of Tokyo Hospital
Division name	Gastrointestinal Surgery
Address	7-3-1, Bunkyo-ku Hongou, Tokyo
TEL	03-3815-5411
Homepage URL
Email	IWATAR-SUR@h.u-tokyo.ac.jp

Sponsor
Institute	University of Tokyo Hospital
Institute
Department

Funding Source
Organization	University of Tokyo Hospital
Organization
Division
Category of Funding Organization	Other
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	2018 Year 01 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 11 Month 30 Day
Anticipated trial start date	2018 Year 01 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	2017 Year 11 Month 29 Day
Last modified on	2018 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034409