UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031755 |
|---|---|
| Receipt number | R000035802 |
| Scientific Title | Prospective Study of Laparoscopic Navigation Surgery with using Indocyanine green-labelled Omental Appendices |
| Date of disclosure of the study information | 2018/03/20 |
| Last modified on | 2019/10/07 23:33:15 |
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Basic information
Public title
Prospective Study of Laparoscopic Navigation Surgery with using Indocyanine green-labelled Omental Appendices
Acronym
ICG-OA navigation surgery
Scientific Title
Prospective Study of Laparoscopic Navigation Surgery with using Indocyanine green-labelled Omental Appendices
Scientific Title:Acronym
ICG-OA navigation surgery
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of laparoscopic navigation surgery with using indocyanine green-labelled omental appendices
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of indocyanine green-labelled omental appendices
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
ICG-labelled omental appendices
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
Histologically proven colorectal cancer.
Stage 0-III.
Patients without iodine hypersensitivity.
age >= 20
Performance status 0-2
Without other primary cancer arising from organs other than colon and rectum
Without iodine hypersensitivity.
Provided written informed consent
Key exclusion criteria
Patients with other primary cancer arising from organs other than colon and rectum.
Severe mental disease
Not appropriate for the study at the physician's assessment
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Hamabe |
Organization
Toyonaka Municipal Hospital
Division name
Department of Surgerye
Zip code
560-8565
Address
4-14-1 Shibahara-cho, Toyonaka, Osaka, Japan
TEL
06-6843-0101
ahamabe1981@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Hamabe |
Organization
Toyonaka Municipal Hospital
Division name
Department of Surgery
Zip code
560-8565
Address
4-14-1 Shibahara-cho, Toyonaka, Osaka, Japan
TEL
06-6843-0101
Homepage URL
ahamabe1981@gmail.com
Sponsor or person
Institute
Toyonaka Municipal Hospital
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
IRB
Address
4-14-1 Shibahara-cho, Toyonaka, Osaka
Tel
06-6843-0101
ahamabe1981@gmail.com
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 | 20 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 14 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 14 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 14 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 15 | Day |
Last modified on
| 2019 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035802
