UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006091 |
|---|---|
| Receipt number | R000007207 |
| Scientific Title | Clinical study on the detection system for intraoperative sentinel lymph node used to ICG in Gastric Cancer |
| Date of disclosure of the study information | 2011/08/02 |
| Last modified on | 2011/08/01 14:09:47 |
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Basic information
Public title
Clinical study on the detection system for intraoperative sentinel lymph node used to ICG in Gastric Cancer
Acronym
Clinical study on sentinel lymph node detection system
Scientific Title
Clinical study on the detection system for intraoperative sentinel lymph node used to ICG in Gastric Cancer
Scientific Title:Acronym
Clinical study on sentinel lymph node detection system
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Reduction of the lymph node dissection in gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Histopathologic diagnosis of lymph node dissection, sentinel lymph node-positive rate,Range of validity of dissection
Key secondary outcomes
Short-term postoperative outcome
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
ICG
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
gastric cancer patient
possible oral intake
PS0,1 patient
Key exclusion criteria
majior complication patient
liver chirrosis patient
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuo Shimada |
Organization
University of Tokushima
Division name
Department of Surgery
Zip code
Address
3-18-15 Kuramoto-cho, Tokushima
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Kurita, |
Organization
University of Tokushima
Division name
Department of Surgery
Zip code
Address
TEL
088-631-3111
Homepage URL
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
University of Tokushima
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 08 | Month | 02 | 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
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 01 | Day |
Last modified on
| 2011 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007207
