UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028457 |
|---|---|
| Receipt number | 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 | 2020/03/03 12:40:53 |
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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 | Daizo |
| Middle name | |
| Last name | Yaguchi |
Organization
Gifu Prefectural Tajimi Hospital
Division name
Deparment of Repiratory Medicine
Zip code
507-8522
Address
5-161, Maehata-cho, Tajimi, Gifu 507-8522, Japan
TEL
0572-22-5311
yaguchi-daizo@tajimi-hospital.jp
Public contact
Name of contact person
| 1st name | Daizo |
| Middle name | |
| Last name | Yaguchi |
Organization
Gifu Prefectural Tajimi Hospital
Division name
Deparment of Repiratory Medicine
Zip code
507-8522
Address
5-161, Maehata-cho, Tajimi, Gifu 507-8522, Japan
TEL
0572-22-5311
Homepage URL
yaguchi-daizo@tajimi-hospital.jp
Sponsor or person
Institute
Gifu Prefectural Tajimi Hospital
Institute
Department
Personal name
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
Gifu Prefectural Tajimi Hospital
Address
5-161, Maehata-cho, Tajimi, Gifu 507-8522, Japan
Tel
0572-22-5311
hatta-masashi@tajimi-hospital.jp
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
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 06 | Day |
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
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032556
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
