UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034564 |
|---|---|
| Receipt number | R000039404 |
| Scientific Title | A Study on Effectiveness of Intraoperative Real Time Blood Flow Evaluation Method of Parathyroid Tissue Using Indocyanine Green (ICG) Fluorescence Method |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2022/10/21 17:05:05 |
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Basic information
Public title
A Study on Effectiveness of Intraoperative Real Time Blood Flow Evaluation Method of Parathyroid Tissue Using Indocyanine Green (ICG) Fluorescence Method
Acronym
Parathyroid blood flow evaluation by ICG fluorescence method
Scientific Title
A Study on Effectiveness of Intraoperative Real Time Blood Flow Evaluation Method of Parathyroid Tissue Using Indocyanine Green (ICG) Fluorescence Method
Scientific Title:Acronym
Parathyroid blood flow evaluation by ICG fluorescence method
Region
| Japan |
Condition
Condition
Thyroid cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Practice and Evaluation of intraoperative real-time blood flow assessment of parathyroid tissue using the ICG fluorescence method in surgery for thyroid cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Availability of blood flow imaging of parathyroid tissue using ICG fluorescence in surgery for thyroid cancer
Key secondary outcomes
To compare the fluorescence concentration of parathyroid tissue visualized by ICG fluorescence method with that of the surrounding tissue and to measure the concentration ratio, in standard surgery (total thyroidectomy or Flocculus resection)
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention period: 1 day
During surgery, 25 mg of ICG is diluted to 5 to 10 ml of water for injection, 0.04 to 0.3 mg / kg is intravenously administered, and then observation is performed using a near infrared scope.
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
1.Consent Acceptance of documents by voluntary free will at the age of over 20 years at the time of acquisition.
2. Histologically or clinically diagnosed as thyroid cancer.
3.Thyroid lobectomy or total thyroidectomy is planned for thyroid tumor.
4. It is the first treatment example for thyroid tumor.
Key exclusion criteria
1.There is a history of hypersensitivity in the ICG preparation.
2.Have clear iodine allergy.
3.Thyroid cancer suspected of parathyroid invasion clinically or imagewise.
4.Other patients judged inappropriate by the doctor in charge of this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ken-ichi |
| Middle name | |
| Last name | Nibu |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Otorhinolaryngology, head and neck surgery
Zip code
6500017
Address
7-5-1, Kusunoki-cho,Chuo-ku, Kobe-city, Hyogo-prefecture, Japan
TEL
078-382-5111
nibu@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Iritani |
Organization
Kobe University Hospital
Division name
Otorhinolaryngology, head and neck surgery
Zip code
6500017
Address
7-5-2, Kusunoki-cho,Chuo-ku, Kobe-city, Hyogo-prefecture, Japan
TEL
078-382-5111
Homepage URL
iritanik@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University 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
Institutional Review Board of Kobe University
Address
7-5-2, Kusunoki-cho,Chuo-ku, Kobe-city, Hyogo-prefecture, Japan
Tel
078-382-6669
cerb@med.kobe-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
| 2019 | Year | 02 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | 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
| 2018 | Year | 10 | Month | 18 | Day |
Last modified on
| 2022 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039404
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