UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038484 |
|---|---|
| Receipt number | R000043853 |
| Scientific Title | Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastric cancer |
| Date of disclosure of the study information | 2020/03/01 |
| Last modified on | 2019/11/03 18:20:21 |
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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 gastric cancer
Acronym
Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastric cancer
Scientific Title
Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastric cancer
Scientific Title:Acronym
Sentinel lymph node navigation surgery with infrared ray electronic endoscopy by local injection of Indocyanine Green in gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
With the concept of the sentinel lymph node navigation surgery by ICG local injection observation using Firefly fluorescence imaging in gastric cancer surgery cases of da Vinci Surgical System for lymphatic flow and metastatic route were controlled, and the efficacy of this method is validated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification rate of sentinel lymph nodes
Key secondary outcomes
None
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 | Device,equipment |
Interventions/Control_1
Indocyanine Green, with the concentration of 5mg/ml, was injected submucosally at four points around the gastric 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 gastric cancer who will undergo curative surgery.
Key exclusion criteria
Patients who refused to join in this study.
Patients who have allergy to Indocyanine Green.
Psychiatric patients.
Pregnant or breastfeeding patients.
Patients with a history of asthma.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Keizo |
| Middle name | |
| Last name | Taniguchi |
Organization
Teikyo University Hospital, Mizonokchi
Division name
Surgery
Zip code
213-8507
Address
5-1-1 Futako, Takatsu-ku, Kawasaki-city
TEL
044-844-3223
keizotng16@me.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Fujimoto |
Organization
Teikyo University Hospital, Mizonokuchi
Division name
Surgery
Zip code
213-8507
Address
5-1-1 Futako, Takatsu-ku, Kawasaki-city
TEL
044-844-3223
Homepage URL
fujimoto@u-fukui.ac.jp
Sponsor or person
Institute
Teikyo University Hospital, Mizonokuchi, Department of Srgery
Institute
Department
Personal name
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
Teikyo University, IRB
Address
2-11-1 Kaga, Itabashi-Ku, Tokyo
Tel
03-3964-7256
turb-office@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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2019 | Year | 11 | Month | 03 | Day |
Last modified on
| 2019 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043853
