UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047324 |
|---|---|
| Receipt number | R000053686 |
| Scientific Title | Observation of anorectal lymphovascular networks using indocyanine green fluorescence imaging |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2023/09/29 20:29:10 |
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Basic information
Public title
Observation of anorectal lymphovascular networks using intraoperative fluorescence imaging
Acronym
Observation of anorectal lymphovascular networks using intraoperative fluorescence imaging
Scientific Title
Observation of anorectal lymphovascular networks using indocyanine green fluorescence imaging
Scientific Title:Acronym
Observation of anorectal lymphovascular networks using indocyanine green fluorescence imaging
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim study is to observe the functional lymphovascular network in the anorectal region using intraoperative indocyanine green fluorescence imaging in patients with rectal cancer.
Basic objectives2
Others
Basic objectives -Others
This study aims to provide the anatomical data to discuss the therapeutic strategies for early and advanced rectal cancer. This study does not aim to expand the indication of indocyanine green, and not to expect therapeutic effects of indocyanine green fluorescence imaging.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome of this study is the data collection of lymphovascular network in the anorectal region. The patient was administered general anesthesia, and then indocyanine green is injected into the submucosa at the anal canal. Intraoperatively, the lymph flow around the anal canal was observed using a laparoscopic near-infrared camera. The data will be the qualitatively, and statistic analyses will not be conducted.
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
Educational,Counseling,Training
Type of intervention
| Medicine |
Interventions/Control_1
The patient was administered general anesthesia, and then 0.25 mg of the dye solution of indocyanine green is injected into the submucosa of the anal canal at the anterior, posterior and bilateral walls prior to the initiation of the operation. The lymph flow around the rectum and anal canal is observed using a laparoscopic near- infrared camera intraoperatively.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria of this study is the patients with stage 0-IV rectal cancer, and other rectal tumors (gastrointestinal stromal tumor, neuroendocrine tumor) who does not undergo preoperative therapy.
Key exclusion criteria
The exclusion criteria of this study is the patients with the histories of allergy for indocyanine green, iodine, and other materials. The patients who do not agree to participate in the study are also be excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sato |
| Middle name | |
| Last name | Kentaro |
Organization
Hakodate Municipal Hospital
Division name
Department of Gastroenterological Surgery
Zip code
041-8680
Address
1-10-1 Minatocho, Hakodate, Hokkaido, Japan
TEL
0138-43-2000
satonumber7or13@gmail.com
Public contact
Name of contact person
| 1st name | Sato |
| Middle name | |
| Last name | Kentaro |
Organization
Hakodate Municipal Hospital
Division name
Department of Gastroenterological Surgery
Zip code
041-8680
Address
1-10-1 Minatocho, Hakodate, Hokkaido, Japan
TEL
0138-43-2000
Homepage URL
satonumber7or13@gmail.com
Sponsor or person
Institute
Hakodate Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee, Hakodate Municipal Hospital
Address
1-10-1 Minatocho, Hakodate, Hokkaido, Japan
Tel
0138-43-2000
chiken@hospital.hakodate.hokkaido.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
| 2022 | Year | 04 | 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
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 30 | 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
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053686
| 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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