UMIN-CTR Clinical Trial

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
Email	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
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	Gifu Prefectural Tajimi Hospital
Address	5-161, Maehata-cho, Tajimi, Gifu 507-8522, Japan
Tel	0572-22-5311
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032556