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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032261
Receipt No. R000036792
Scientific Title Partial gastrectomy with sentinel node mapping using image-guided fluorescence navigation system with indocyanine green by for clinical stage I gastric cancer with high risk status
Date of disclosure of the study information 2018/04/16
Last modified on 2018/04/16

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Basic information
Public title Partial gastrectomy with sentinel node mapping using image-guided fluorescence navigation system with indocyanine green by for clinical stage I gastric cancer with high risk status
Acronym Partial gastrectomy for clinical stage I gastroic cancer with high risk status
Scientific Title Partial gastrectomy with sentinel node mapping using image-guided fluorescence navigation system with indocyanine green by for clinical stage I gastric cancer with high risk status
Scientific Title:Acronym Partial gastrectomy for clinical stage I gastroic cancer with high risk status
Region
Japan

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

Objectives
Narrative objectives1 To investigate clinical benefit of partial gastrectomy concomitantly with sentinel node dissection using image-guided fluorescence navigation system with indocyanine green for clinical stage I gastric cancer with high risk comorbidity
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Incidence of postoperative complications
Key secondary outcomes Relapse free survival
Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Localized gastrectomy for stage I gastric cancer with severe preoperative complications
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
75 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria cN0, ASA >3
Key exclusion criteria cN+, esophagogastric junctional cancer
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyohiko Shuto
Organization Teikyo University Chiba Medican Center
Division name Surgery
Zip code
Address 3426-3 Anesaki, Ichihara, Chiba
TEL 0436621211
Email kshuto@med.teikyo-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kiyohiko Shuto
Organization Teikyo University Chiba Medican Center
Division name Surgery
Zip code
Address 3426-3 Anesaki, Ichihara, Chiba
TEL 0436621211
Homepage URL
Email kshuto@med.teikyo-u.ac.jp

Sponsor
Institute Teikyo University Chiba Medical Center
Institute
Department

Funding Source
Organization Teikyo University
Organization
Division
Category of Funding Organization Other
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 帝京大学ちば総合医療センター

Other administrative information
Date of disclosure of the study information
2018 Year 04 Month 16 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 Enrolling by invitation
Date of protocol fixation
2016 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 20 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
2018 Year 04 Month 16 Day
Last modified on
2018 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036792

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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