UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009774 |
|---|---|
| Receipt number | R000011447 |
| Scientific Title | Randomized controlled trial of bronchial occlusion methods in intractable pneumothorax or bronchopleural fistula |
| Date of disclosure of the study information | 2013/01/14 |
| Last modified on | 2015/10/02 18:53:21 |
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Basic information
Public title
Randomized controlled trial of bronchial occlusion methods in intractable pneumothorax or bronchopleural fistula
Acronym
Bronchial occlusion in intractable pneumothorax
Scientific Title
Randomized controlled trial of bronchial occlusion methods in intractable pneumothorax or bronchopleural fistula
Scientific Title:Acronym
Bronchial occlusion in intractable pneumothorax
Region
| Japan |
Condition
Condition
Pneumothorax or bronchopleural fistula.
Classification by specialty
| Pneumology | Chest surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effectiveness of the silicone bronchial blocker - Endobronchial Watanabe Spigot (EWS) TM - compared with fibrin glue for treatment of intractable pneumothorax or bronchopleural fistula.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether air leaks are resolved. Whether air leaks are reduced. Amount of time to resolution or reduction of air-leaks.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Interventions. Bronchial occlusion with the silicone bronchial blockers -EWS TM-.
Interventions/Control_2
Control. Bronchial occlusion with fibrin glue.
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
Patients with pneumothorax or bronchopleural fistula who have persistent air leaks for 3 days or longer.
Key exclusion criteria
Patients with uncontrolled infectious diseases. Patients with severe respiratory failure requiring 6 liters per min or 60% of oxygen supplementation to keep oxygen saturation above 90% measured by pulse oximeters. Pregnant women.
Patients who cannot tolerate tracheal intubation or bronchoscopy. Uncooperative patients.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kengo Murata |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Respiratory medicine
Zip code
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengo Murata |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Respiratory Medicine
Zip code
Address
TEL
042-323-5111
Homepage URL
kengo_murata@tmhp.jp
Sponsor or person
Institute
Respiratory Medicine, Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Goverment
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 01 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ers-education.org/events/international-congress/amsterdam-2015.aspx?idParent=144696
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
Main results already published
Date of protocol fixation
| 2009 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 02 | Month | 05 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 05 | Day |
Date analysis concluded
| 2015 | Year | 02 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 13 | Day |
Last modified on
| 2015 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011447
