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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022991
Receipt No. 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

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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)
Email 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
Email satom-sur@h.u-tokyo.ac.jp

Sponsor
Institute Ministry of health, labor, and welfare
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026500

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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