UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047255 |
|---|---|
| Receipt number | R000053897 |
| Scientific Title | Study of blood level and fluorescence in infrared light thoracoscopic segmentectomy using Indocyanine Green |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2025/03/25 12:35:20 |
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Basic information
Public title
Study of blood level and fluorescence in infrared light thoracoscopic segmentectomy using Indocyanine Green
Acronym
Relationship between blood levels of indocyanine green and fluorescence during segmentectomy.
Scientific Title
Study of blood level and fluorescence in infrared light thoracoscopic segmentectomy using Indocyanine Green
Scientific Title:Acronym
Relationship between blood levels of indocyanine green and fluorescence during segmentectomy.
Region
| Japan |
Condition
Condition
Patients scheduled for segmentectomy
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the relationship between optimal rate and blood level of ICG and fluorescence brightness at doses within 0.3 mg/kg of the insurance approved intravenous administration method of ICG for identification between zones in patients scheduled for pulmonary zonectomy, and to obtain stable and clear fluorescence.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intersegmental line identification rate
Key secondary outcomes
ICG dosage and rate, operating time, blood loss, complications and rates, duration of drainage, length of hospital stay, Changes in respiratory function tests
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
ICG is administered intravenously at a determined dosing rate based on cardiac output
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
1) Patients scheduled for thoracoscopic segmentectomy, for whom an explanation is given and written consent is confirmed.
2) Patients must be 20 years of age or older at the time of enrollment.
3) Patients with a Performance status of 0-3
4) Patients without liver failure or severe cirrhosis
5) Patients without severe heart failure
6) Patients who have given their written consent to participate in the study.
Key exclusion criteria
1) Patients allergic to iodine or ICG
2) Patients who underwent open chest or lobectomy prior to ICG administration for intersegmental line identification
3) Cases with a Child pugh classification of B or higher
4) NYHA (New York Heart Association) classification: Grade III or higher
5) Pregnant, lactating, or possibly pregnant
6) Cases with serious complications
7) Other cases deemed inappropriate by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Misaki |
Organization
Faculty of medicine, Kagawa University
Division name
General thoracic surgery
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun
TEL
0788985111
gazyucup@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Noriyuki |
| Middle name | |
| Last name | Misaki |
Organization
Faculty of medicine, Kagawa University
Division name
General thoracic surgery
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun
TEL
0788985111
Homepage URL
gazyucup@yahoo.co.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Noriyuki Misaki
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagawa university
Address
1750-1Ikenobe, Miki-cho, Kita-gun
Tel
0788985111
md-chiken@kagawa-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
| 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
30
Results
Blood concentrations of ICG were successfully stabilized, with good Intersegmental plane identifiy and marking success rates of 100% and 93.3%, respectively.
Results date posted
| 2025 | Year | 03 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No cases met the exclusion criteria, and all cases were eligible for inclusion.
Participant flow
Adverse events
No adverse events related to inter-area identification using ICG were observed.
Outcome measures
Intersegmental plane marking success rate
ICG blood concentration
Fluorescence intensity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 23 | Day |
Last modified on
| 2025 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053897
