UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032261 |
|---|---|
| Receipt number | 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 | 2021/01/18 18:42:36 |
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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 | Kiyohiko |
| Middle name | |
| Last name | Shuto |
Organization
Teikyo University Chiba Medican Center
Division name
Surgery
Zip code
2990111
Address
3426-3 Anesaki, Ichihara, Chiba
TEL
0436621211
kshuto@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyohiko |
| Middle name | |
| Last name | Shuto |
Organization
Teikyo University Chiba Medican Center
Division name
Surgery
Zip code
2990111
Address
3426-3 Anesaki, Ichihara, Chiba
TEL
0436621211
Homepage URL
kshuto@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University Chiba Medical Center
Institute
Department
Personal name
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
Teikyo University Chiba Medical Center
Address
3426-3 Anesaki, Ichihara, Chiba
Tel
0436621211
kshuto@med.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
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
| 2016 | Year | 05 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2029 | 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
| 2018 | Year | 04 | Month | 16 | Day |
Last modified on
| 2021 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036792
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
