UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Title of the study (Brief title)	Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate availability of ICG detection by near-infrared scopes on determination of the transection line during gastrectomy for early gastric cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Differences in length between preoperatively-determined and actual surgical margins
Key secondary outcomes	Detection rate of ICG during gastrectomy, size of visualized ICG, morbidity of preoperative upper endoscopy, prevalence of adverse effects of ICG injection, operative time, intraoperative estimated blood loss, pathological findings (e.g. tumor depth, proximal and distal margin), postoperative morbidity rate, frequency of additional resection

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 Maneuver
Interventions/Control_1	ICG injection by near-infrared scopes
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) patients who are histologically proven gastric adenocarcinoma 2) patients who are diagnosed clinical T1 according to the 14th edition of Japanese Classification of Gastric Carcinoma 3) patients who receive informed consent
Key exclusion criteria	1) patients who have allergy to ICG 2) patients who have allergy to iodine 3) patients who are judged to be ineligible for subject by resercher
Target sample size	120

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL	052-744-2249
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	Chie Tanaka
Organization	Nagoya University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery
Address	65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL	052-744-2250
Homepage URL
Email	chtanaka@med.nagoya-u.ac.jp

Sponsor
Institute	Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Nagoya Univerisity
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	2016 Year 01 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 12 Month 31 Day
Anticipated trial start date	2016 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	prospective study

Management information
Registered date	2015 Year 09 Month 02 Day
Last modified on	2017 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021813