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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020187
Receipt No. R000023313
Scientific Title Prospectiev study of safety and efficiency of bronchial artery occlusion for lung and mediastinal tumor
Date of disclosure of the study information 2015/12/14
Last modified on 2019/10/02

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Basic information
Public title Prospectiev study of safety and efficiency of bronchial artery occlusion for lung and mediastinal tumor
Acronym Prospectivey study of bronchial artery embolization for lung and mediastinal tumor
Scientific Title Prospectiev study of safety and efficiency of bronchial artery occlusion for lung and mediastinal tumor
Scientific Title:Acronym Prospectivey study of bronchial artery embolization for lung and mediastinal tumor
Region
Japan

Condition
Condition Lung and mediastinal malignant tumor
Classification by specialty
Medicine in general Pneumology Surgery in general
Chest surgery Cardiovascular surgery Emergency medicine
Intensive care medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety and efficiency of bronchial artery embolization for lung hilar and mediastinal malignant tumor are prospectively examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety and anti-tumor effect of bronchial artery embolization for lung and mediastinal tumor are examined.Safety is checked by physical and radiological findings of spinal palsy, esophageal inflammation, and bronchial inflammation, within one week after the treatment. Anti-tumor effect is checked by CT, MRI, and FDG-PET for decreasing tumor around one month after the treatment.
Key secondary outcomes

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Bronchial aretery embolization using NBCA, which is usually used for airway bleeding caused by inflammatory lesion, is used for reducing malignant lung and mediastinal tumor.
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
1 years-old <=
Age-upper limit
110 years-old >=
Gender Male and Female
Key inclusion criteria Malignant lung and mediastinal tumors.
The tumor is located near hilum or mediastinum.
Key exclusion criteria The patient who rejects the treatment after explaining the treatment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Nomori
Organization Kameda Medical Center
Division name Thoracic Surgery
Zip code
Address 929 Higashi-cho, Kamogawa, Chiba
TEL 0470-92-2211
Email hnomori@qk9.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Nomori
Organization Kameda Medical Center
Division name Thoracic Surgery
Zip code
Address 929 Higashi-cho, Kamogawa, Chiba
TEL 0470-92-2211
Homepage URL
Email hnomori@qk9.so-net.ne.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

Funding Source
Organization Self funding
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
Email

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
2015 Year 12 Month 14 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
2015 Year 12 Month 09 Day
Date of IRB
2015 Year 12 Month 09 Day
Anticipated trial start date
2015 Year 12 Month 15 Day
Last follow-up date
2020 Year 12 Month 01 Day
Date of closure to data entry
2020 Year 12 Month 01 Day
Date trial data considered complete
2020 Year 12 Month 01 Day
Date analysis concluded
2020 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2015 Year 12 Month 14 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023313

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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