UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025166 |
|---|---|
| Receipt number | R000028950 |
| Scientific Title | Changes in pulmonary function tests and respiratory symptoms after airway stent removal |
| Date of disclosure of the study information | 2016/12/07 |
| Last modified on | 2021/10/21 23:16:00 |
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Basic information
Public title
Changes in pulmonary function tests and respiratory symptoms after airway stent removal
Acronym
Pulmonary function after airway stent removal
Scientific Title
Changes in pulmonary function tests and respiratory symptoms after airway stent removal
Scientific Title:Acronym
Pulmonary function after airway stent removal
Region
| Japan |
Condition
Condition
Airway stenotic diseases
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate changes in pulmonary function and respiratory symptoms after vs. before airway stent removal
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Changes in pulmonary function test results (peak expiratory flow) after vs. before airway stent removal
Key secondary outcomes
1. Changes in pulmonary function test results (FVC, FEV1) after airway stent removal
2. Changes in respiratory symptoms (frequency of coughing, amount of sputum, difficulty of expectoration, dyspnea) assessed by a visual analog scale after vs. before airway stent removal
3. Frequency of airway stent re-insertion
4. Incidence of adverse effects
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Patients with an airway stent who require stent removal because of a response to tumor-specific therapy or stent-related respiratory symptoms
2. 20 years old or older
3. Informed consent
Key exclusion criteria
1. Patients expected to need stent re-insertion in the same setting as stent removal
2. Patients with multiple stents expected to undergo the removal of only some of them
3. Patients who cannot perform pulmonary function testing (e.g., patients with a tracheostomy or who are on mechanical ventilation)
4. Patients who cannot assess their respiratory symptoms using a visual analog scale
5. Patients who require stent removal due to stent migration
6. Patients who require bronchoscopic procedures other than stent removal (e.g., ablation of tumor or granulation tissue) in the same setting
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahide Oki |
Organization
Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
masahideo@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahide Oki |
Organization
Nagoya Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
4-1-1 Sannomaru, Naka-ku, Nagoya 460-0001, Japan
TEL
052-951-1111
Homepage URL
masahideo@gmail.com
Sponsor or person
Institute
Nagoya Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
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
| 2016 | Year | 12 | Month | 07 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective consecutive study
Management information
Registered date
| 2016 | Year | 12 | Month | 06 | Day |
Last modified on
| 2021 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028950
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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