UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030978 |
|---|---|
| Receipt number | R000035373 |
| Scientific Title | Study of Indocyanine green for gastrectomy |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/08/07 22:41:45 |
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Basic information
Public title
Study of Indocyanine green for gastrectomy
Acronym
Study of Indocyanine green for gastrectomy
Scientific Title
Study of Indocyanine green for gastrectomy
Scientific Title:Acronym
Study of Indocyanine green for gastrectomy
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Several factors such as lymphatic flow, blood supply, and so on are assessed by using indocyanine green during gastrectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of Assessment of several factors such as lymphatic flow, blood supply, and so on.
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Indocyanine green is given to the patients who will undergo gastrectomy on operation day or preopratively
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patitent who undergo robotic or laparscopic gastrectomy are enrolled.
Each patient is assessed whether Indocyanine green is required or not preoperatively.
Key exclusion criteria
Exclusion criteria are as follows.
1) Patients who are pregnant or breastfeeding.
2) Patients who have psychiatric problems and, are regarded difficult to participate the study.
3) Patients who are allergic to iodine.
4) Patients who are in unstable condition and regarded difficult to participate the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Kojima |
Organization
Tokyo Medical and Dental University
Division name
Center for Minimally Invasive Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5260
k-kojima.srg2@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Nakagawa |
Organization
Tokyo Medical and Dental University
Division name
Department of Gastric Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5254
Homepage URL
nakagawa.srg1@tmd.ac.jp
Sponsor or person
Institute
Department of Gastric Surgery, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastric Surgery, Tokyo Medical and Dental University
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
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
| 2018 | 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
| 2018 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 08 | Month | 09 | 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 | 01 | Month | 24 | Day |
Last modified on
| 2018 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035373
