UMIN-CTR Clinical Trial

Basic information
Public title	Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastric cancer
Acronym	Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastric cancer
Scientific Title	Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastric cancer
Scientific Title:Acronym	Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	With the concept of the sentinel lymph node navigation surgery by ICG local injection observation using Firefly fluorescence imaging in gastric cancer surgery cases of da Vinci Surgical System for lymphatic flow and metastatic route were controlled, and the efficacy of this method is validated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Identification rate of sentinel lymph nodes
Key secondary outcomes	None

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 Device,equipment
Interventions/Control_1	Indocyanine Green, with the concentration of 5mg/ml, was injected submucosally at four points around the gastric tumor
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	Patients with the diagnosis of gastric cancer who will undergo curative surgery.
Key exclusion criteria	Patients who refused to join in this study. Patients who have allergy to Indocyanine Green. Psychiatric patients. Pregnant or breastfeeding patients. Patients with a history of asthma.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Keizo Middle name Last name Taniguchi
Organization	Teikyo University Hospital, Mizonokchi
Division name	Surgery
Zip code	213-8507
Address	5-1-1 Futako, Takatsu-ku, Kawasaki-city
TEL	044-844-3223
Email	keizotng16@me.com

Public contact
Name of contact person	1st name Daisuke Middle name Last name Fujimoto
Organization	Teikyo University Hospital, Mizonokuchi
Division name	Surgery
Zip code	213-8507
Address	5-1-1 Futako, Takatsu-ku, Kawasaki-city
TEL	044-844-3223
Homepage URL
Email	fujimoto@u-fukui.ac.jp

Sponsor
Institute	Teikyo University Hospital, Mizonokuchi, Department of Srgery
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)

IRB Contact (For public release)
Organization	Teikyo University, IRB
Address	2-11-1 Kaga, Itabashi-Ku, Tokyo
Tel	03-3964-7256
Email	turb-office@teikyo-u.ac.jp

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	2020 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 11 Month 03 Day
Date of IRB
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 11 Month 03 Day
Last modified on	2019 Year 11 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043853