UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022991 |
|---|---|
| Receipt number | R000026500 |
| Scientific Title | Bronchoscopic lung marking to resect small pulmonary lesions: an open-label, uncontrolled, single-arm study |
| Date of disclosure of the study information | 2016/07/03 |
| Last modified on | 2018/03/19 23:24:15 |
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Basic information
Public title
Bronchoscopic lung marking to resect small pulmonary lesions: an open-label, uncontrolled, single-arm study
Acronym
Bronchoscopic lung marking to resect small pulmonary lesions
Scientific Title
Bronchoscopic lung marking to resect small pulmonary lesions: an open-label, uncontrolled, single-arm study
Scientific Title:Acronym
Bronchoscopic lung marking to resect small pulmonary lesions
Region
| Japan |
Condition
Condition
A pulmonary lesion suspected or diagnosed as malignancy
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy and safety of bronchoscopic lung marking and following thoracoscopic lung resection for small pulmonary lesions suspected of malignancy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Successful resection of pulmonary lesions with sufficient resection margins*
*Resection margins larger than the tumor diameter or 2 cm
Key secondary outcomes
1) Efficacy of markings
2) Efficacy of marking-assisted surgery
3) Safety (observed until post-operative day 30)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Bronchoscopic lung marking (Only once)
Surgery (conducted within 2 days after bronchoscopic lung marking)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A pulmonary lesion or lesions suspected of or diagnosed with malignancy, the resection of which needs determination of resection lines other than standard lobectomy
2) A pulomnary lesion or lesions that is anticipated to be hardly identifiable during surgery and necessitate careful determination of resection lines to obtain sufficient resection margins, including:
A) A lesion or lesions anticipated to be hardly identifiable during surgery due to the lesion's characteristics such as
i) A component of ground glass opacity as a part or a whole of the lesion
ii) A lesion the diameter of which is smaller than or equal to 5 mm
iii) A lesion the distance from the closest visceral pleura is larger than the lesion's diameter
B) A pulmonary lesion or lesions anticipated to be hardly identifiable during surgery because of the condition of the underlying lung such as
i) Anticipated tight pleural adhesion (e.g, previous open chest surgery)
ii) Existence of confusing benign nodules (e.g., silicosis, old tuberculosis)
C) Other lesions or conditions fo which surgeons consider markings are particularly necessary
3) Consent obtained from the patient or a representative
4) At least two certified thoracic surgeons agree with the necessity of markings at the time of registration
Key exclusion criteria
1) Allergic to indigocarmine
2) Pregnant
3) Complications that do not allow for bronchoscopy or the marking procedure
4) Other cases a medical doctor in charge judged as inappropriate for registeration
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Sato |
Organization
The University of Tokyo Hospital
Division name
Thoracic Surgery
Zip code
Address
7-3-1, Hogo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411(34870)
satom-sur@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Sato |
Organization
The University of Tokyo Hospital
Division name
Thoracic Surgery
Zip code
Address
7-3-1, Hogo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411(34870)
Homepage URL
satom-sur@h.u-tokyo.ac.jp
Sponsor or person
Institute
Ministry of health, labor, and welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
P2015037-11Y
Org. issuing International ID_1
The University of Tokyo Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京大学医医学部附属病院（東京都）
東京女子医大八千代医療センター（千葉県）
総合病院 国保旭中央病院（千葉県）
順天堂大学附属順天堂医院（東京都）
聖路加国際病院（東京都）
東京医科歯科大学医学部附属病院（東京都）
湘南鎌倉総合病院（神奈川県）
新潟大学医歯学総合病院（新潟県）
相澤病院（長野県）
長良医療センター（岐阜県）
田附興風会医学研究所北野病院（大阪府）
兵庫県立尼崎総合医療センター（兵庫県）
松江赤十字病院（島根県）
島根県立中央病院（島根県）
産業医科大学病院（福岡県）
NTT東日本関東病院（東京都）
日本赤十字社医療センター（東京都）
長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 03 | 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
| 2016 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 10 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 03 | Day |
Last modified on
| 2018 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026500
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
