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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020507
Receipt No. R000023668
Scientific Title Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in esophagogastric cancer
Date of disclosure of the study information 2016/02/08
Last modified on 2016/01/08

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

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

Objectives
Narrative objectives1 With the concept of sentinel node navigation surgery with infrared ray electronic endoscopy after local injection of indocyanine Green, lymphatic flow and metastatic route in lymph node metastasis were assessed, and the efficacy of this procedure is validated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Identification rate of sentinel lymph nodes
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 Device,equipment
Interventions/Control_1 Indocyanine Green, with the concentration of 5mg/ml, was injected submucosally at four points around the 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 esophageal or gastric cancer who will undergo curative surgery.
Key exclusion criteria Patients who refused to join in this study.
Patients with clinically advanced gastric cancer.
Patients who have allergy to Indocyanine Green.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Sakai
Organization Kyoto University Hospital
Division name Surgery
Zip code
Address 54, Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-366-7595
Email ysakai@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hisashi Shinohara
Organization Kyoto University Hospital
Division name Surgery
Zip code
Address 54, Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-366-7595
Homepage URL
Email shinosug@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital, Department of Surgery
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
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 02 Month 08 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
2016 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 03 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

Management information
Registered date
2016 Year 01 Month 08 Day
Last modified on
2016 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023668

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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