UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030911 |
|---|---|
| Receipt number | R000034532 |
| Scientific Title | Study for safety and usefulness of thoracoscopic segmentectomy using infrared thoracoscope with indocyanine green(ICG) |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2018/01/20 16:33:26 |
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Basic information
Public title
Study for safety and usefulness of thoracoscopic segmentectomy using infrared thoracoscope with indocyanine green(ICG)
Acronym
Study for safety and usefulness of thoracoscopic segmentectomy using indocyanine green(ICG)
Scientific Title
Study for safety and usefulness of thoracoscopic segmentectomy using infrared thoracoscope with indocyanine green(ICG)
Scientific Title:Acronym
Study for safety and usefulness of thoracoscopic segmentectomy using indocyanine green(ICG)
Region
| Japan |
Condition
Condition
lung cancer, lung cancer suspected
metastatic lung tumor, metastatic lung tumor suspected
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We study the usefulness and safety of the infrared endoscope system with indocyanine green (ICG) for identification of segmental plane in thoracoscopic lung segmentectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morbidity ratio and ratio of identification of segmental plane for ICG infrared thoracoscopic technique
Key secondary outcomes
Coincidence ratio of identification of segmental plane between anatomical method, inflation-deflation technique and ICG infrared thoracoscopic technique.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Indocyanine green 0.25mg/kg is injected into a peripheral vein.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients over 20 years old and under 90 years old in obtaining written informed consent.
2. Patients with lung cancer or metastatic lung tumor are considered as an indication of lung segmentectomy.
3. Patients with obtaining written informed consent.
Key exclusion criteria
1. Patients with a history of side effects from ICG
2. Patients with iodine hypersensitivity
3. Women who are likely to be pregnant and possibly pregnant
4. Patients who are thought to be difficult to undergo thoracoscopic lung segmentectomy depending on the degree of tumor progression
5. Patients judged to be unable to tolerate general anesthesia, such as severe heart disease
6. Patients with infection requiring systemic treatment
7. Patients with fever at surgery
8. Patients who are complicated with psychosis or psychiatric symptoms and are considered difficult to participate in the study
9. Patients who can not obtain consent of transfusion
10. Clinicians decide to exclude from this trial in some reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Haneda |
Organization
Nagoya City University, Graduate School of Medical Sciences
Division name
Oncology, Immunology and Surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8231
h-haneda@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Haneda |
Organization
Nagoya City University, Graduate School of Medical Sciences
Division name
Oncology, Immunology and Surgery
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-853-8231
Homepage URL
h-haneda@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Oncology, Immunology and Surgery, Nagoya City University, Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Oncology, Immunology and Surgery, Nagoya City University, Graduate School of Medical Sciences
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 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | 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 | 20 | Day |
Last modified on
| 2018 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034532
