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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025201
Receipt No. R000028995
Scientific Title Exploratory Research for the therapy of Endobronchial ultrasound-guided transbronchial ethanol injection.
Date of disclosure of the study information 2016/12/09
Last modified on 2016/12/09

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Basic information
Public title Exploratory Research for the therapy of Endobronchial ultrasound-guided transbronchial ethanol injection.
Acronym Exploratory Research for the therapy of EBUS-TBEI.
Scientific Title Exploratory Research for the therapy of Endobronchial ultrasound-guided transbronchial ethanol injection.
Scientific Title:Acronym Exploratory Research for the therapy of EBUS-TBEI.
Region
Japan

Condition
Condition Airway obstruction due to lung cancer or metastatic lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate efficacy and safety of Endobronchial ultrasound-guided transbronchial ethanol injection therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The presence or absence of improvement in the airway obstruction.
Key secondary outcomes Size change of ethanol injected tumor.

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 Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 ethanol injection
0.2-0.4ml injection each time
total maximum 2ml
Repeat once or twice a week
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 Definitive diagnosis of lung cancer or metastatic lung tumor by the tissue examination or cytology.
2 unresectable and radical irradiation inability
3 More than one month of survival can be expected
4 Cases that the airway is constricted
5 Informed consent must be taken
Key exclusion criteria 1 Cases that can be treated by only irradiation.
2 The doctor's disagrement for the registration due to some underlying medical conditon
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mikio Takamori
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of respiratory medicine and clinical oncology
Zip code
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 042-323-5111
Email mikio_takamori@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mikio Takamori
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of respiratory medicine and clinical oncology
Zip code
Address 2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL 042-323-5111
Homepage URL
Email mikio_takamori@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Department of respiratory medicine and clinical oncology
Institute
Department

Funding Source
Organization Tokyo Metropolitan Tama Medical Center
Department of respiratory medicine and clinical oncology
Organization
Division
Category of Funding Organization Other
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 東京都立多摩総合医療センター

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 09 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 Open public recruiting
Date of protocol fixation
2016 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 09 Day
Last modified on
2016 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028995

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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