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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028457
Receipt No. R000032556
Scientific Title Bronchoscopic local steroid injection to prevent bronchial tuberculosis-induced cicatricial bronchial stenosis.
Date of disclosure of the study information 2017/07/31
Last modified on 2018/02/15

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Basic information
Public title Bronchoscopic local steroid injection to prevent bronchial tuberculosis-induced cicatricial bronchial stenosis.
Acronym To prevent tuberculous bronchial stenosis by Bronchoscopic local steroid injection
Scientific Title Bronchoscopic local steroid injection to prevent bronchial tuberculosis-induced cicatricial bronchial stenosis.
Scientific Title:Acronym To prevent tuberculous bronchial stenosis by Bronchoscopic local steroid injection
Region
Japan

Condition
Condition tracheobronchial tuberculosis
Classification by specialty
Pneumology Infectious disease Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prevent bronchial tuberculosis-induced cicatricial bronchial stenosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether bronchial cicatrical stenosis could be avoided
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 Bronchoscopic local steroid injection with triamcinolone acetonide (Maximum dose:30mg) was administered at target lesion for 1-3 weeks, several times in total. Referring to Arai's classification of bronchoscopic findings of bronchial tuberculosis (JJSRE 2001), as a aim of termination of treatment, the point at which bronchoscopic findings shift to ulcerative lesion (Type III) disappearing or granulation type (Type IV).
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Subjects able to understand the written informed consent and willing to participate evidenced by signing the informed consent.
2)Tracheobronchial tuberculosis is diagnosed in our hospital, Referring to Arai's classification of bronchoscopic findings of bronchial tuberculosis (JJSRE2001), we selected Type IIIb (protruding ulcer type) cases, which are likely to develop cicatricial stenosis in the future, in which active lesions extended in the transverse direction and occupied 1/2 or more of the circumference on bronchoscopy.
Key exclusion criteria 1)When the lesion is extensive
2)Subjects deemed by the investigator to be inappropriate according for inclusion in the study.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daizo Yaguchi
Organization Gifu Prefectural Tajimi Hospital
Division name Deparment of Repiratory Medicine
Zip code
Address 5-161, Maehata-cho, Tajimi, Gifu 507-8522, Japan
TEL 0572-22-5311
Email yaguchi-daizo@tajimi-hospital.jp

Public contact
Name of contact person
1st name
Middle name
Last name Daizo Yaguchi
Organization Gifu Prefectural Tajimi Hospital
Division name Deparment of Repiratory Medicine
Zip code
Address 5-161, Maehata-cho, Tajimi, Gifu 507-8522, Japan
TEL 0572-22-5311
Homepage URL
Email yaguchi-daizo@tajimi-hospital.jp

Sponsor
Institute Gifu Prefectural Tajimi Hospital
Institute
Department

Funding Source
Organization Gifu Prefectural Tajimi Hospital
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
2017 Year 07 Month 31 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 07 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
2017 Year 07 Month 31 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032556

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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