UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036153 |
|---|---|
| Receipt number | R000041193 |
| Scientific Title | Study the usefulness bronchial brushing of for diagnosis of pulmonary mycobacterium avium complex disaese |
| Date of disclosure of the study information | 2019/03/11 |
| Last modified on | 2022/05/19 20:13:41 |
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Basic information
Public title
Study the usefulness bronchial brushing of for diagnosis of pulmonary mycobacterium avium complex disaese
Acronym
Study the usefulness bronchial brushing of for diagnosis of pulmonary mycobacterium avium complex disaese
Scientific Title
Study the usefulness bronchial brushing of for diagnosis of pulmonary mycobacterium avium complex disaese
Scientific Title:Acronym
Study the usefulness bronchial brushing of for diagnosis of pulmonary mycobacterium avium complex disaese
Region
| Japan |
Condition
Condition
pulmonary Mycobacterium avium complex infection
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the usefulness of bronchoscopic brushing for diagnosis in patients with Mycobacterium avium complex lung disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Culture positive rate of washing solution before and after bronchial brushing
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
When carrying out the bronchoscopic examination, perform the inspection in the order of washing,brush abrasion,washing and compare the culture results of the washing solution before and after brush abrasion.
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A case in which pulmonary MAC disease was suspected and a bronchoscopic examination was performed within the subject period.
Key exclusion criteria
20 years or younger
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Urabe |
Organization
Toho University Omori Medical Center,
Division name
Department of Respiratory Medicine
Zip code
143-8540
Address
6-11-1 Omori-nishi, Otaku, Tokyo
TEL
+81-3-3762-4151
naohisa.urabe@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Naohisa |
| Middle name | |
| Last name | Urabe |
Organization
Toho University Omori Medical Center,
Division name
Department of Respiratory Medicine
Zip code
143-8540
Address
6-11-1 Omori-nishi, Otaku, Tokyo
TEL
+81-3-3762-4151
Homepage URL
naohisa.urabe@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho University Omori Medical Center
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
Toho University Omori Medical Center
Address
6-11-1 Omori-nishi, Otaku, Tokyo
Tel
+81-3-3762-4151
naohisa.urabe@med.toho-u.ac.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
| 2019 | Year | 03 | Month | 11 | Day |
Related information
URL releasing protocol
https://www.karger.com/Article/FullText/515605
Publication of results
Published
Result
URL related to results and publications
https://www.karger.com/Article/FullText/515605
Number of participants that the trial has enrolled
69
Results
NTM was detected in 37 of the 69 (53.6%) patients. NTM was detected in 34 (49.3%) pre-brushing samples, in 27 (39.1%) post-brushing samples, and in 20 (29.0%) brush samples from the 69 patients. In 2 (2.9%) patients, NTM was detected only in post-brushing samples; in 1 (1.4%) patient, NTM was detected only in a brush sample. As compared with bronchial washing only, additional bronchial brushing increased the NTM culture-positive rate by 4.3% (3/69).
Results date posted
| 2022 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sixty-nine patients with suspected pulmonary NTM disease, with small nodular infiltrates with or without bronchiectasis on chest CT images, prospectively underwent bronchoscopy examination
Participant flow
The bronchoscopy procedure is follow, First, we performed bronchial washing at the most affected segmental or subsegmental bronchi, as determined by chest CT. Second, bronchial brushing of the same lesion was done for 10 seconds (BC-202D-1210, OLYMPUS, Tokyo, Japan) (Fig. 2). Finally, bronchial washing was repeated. Bronchial washing was done with 20 to 40 ml of normal sterile saline, and samples of bronchial washing fluid were collected before and after bronchial brushing
Adverse events
Bronchial brushing resulted in bronchial bleeding requiring hemostatic treatment in 5 patients. Bleeding improved promptly in all these patients, and no subsequent complications such as pneumonia or hemoptysis were observed
Outcome measures
Compare the NTM culture positivity rate of each sample to determine the usefulness of brush abrasion.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041193
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