UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020187 |
|---|---|
| Receipt number | 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 11:27:56 |
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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
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
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023313
