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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018890
Receipt No. R000021813
Scientific Title Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Date of disclosure of the study information 2016/01/01
Last modified on 2017/07/04

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Basic information
Public title Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Acronym Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Scientific Title Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Yasuhiro Kodera
Organization Nagoya University Graduate School of Medicine

Division name Department of Gastroenterological Surgery
Zip code
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
1st name
Middle name
Last name Chie Tanaka
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterological Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 31 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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