UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Indocyanine green for gastrectomy
Title of the study (Brief title)	Study of Indocyanine green for gastrectomy
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Several factors such as lymphatic flow, blood supply, and so on are assessed by using indocyanine green during gastrectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of Assessment of several factors such as lymphatic flow, blood supply, and so on.
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	Prevention
Type of intervention	Other
Interventions/Control_1	Indocyanine green is given to the patients who will undergo gastrectomy on operation day or preopratively
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patitent who undergo robotic or laparscopic gastrectomy are enrolled. Each patient is assessed whether Indocyanine green is required or not preoperatively.
Key exclusion criteria	Exclusion criteria are as follows. 1) Patients who are pregnant or breastfeeding. 2) Patients who have psychiatric problems and, are regarded difficult to participate the study. 3) Patients who are allergic to iodine. 4) Patients who are in unstable condition and regarded difficult to participate the study.
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuyuki Kojima
Organization	Tokyo Medical and Dental University
Division name	Center for Minimally Invasive Surgery
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5260
Email	k-kojima.srg2@tmd.ac.jp

Public contact
Name of contact person	Masatoshi Nakagawa
Organization	Tokyo Medical and Dental University
Division name	Department of Gastric Surgery
Address	1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-5803-5254
Homepage URL
Email	nakagawa.srg1@tmd.ac.jp

Sponsor
Institute	Department of Gastric Surgery, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Department of Gastric Surgery, Tokyo Medical and Dental 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	2018 Year 03 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 24 Day
Anticipated trial start date	2018 Year 08 Month 09 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	2018 Year 01 Month 24 Day
Last modified on	2018 Year 08 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035373