UMIN-CTR Clinical Trial

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