UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025587 |
|---|---|
| Receipt number | R000029446 |
| Scientific Title | The effect of inhaled bronchodilators on surgery for lung cancer surgery in patients with chronic obstructive lung disease; multicenter study |
| Date of disclosure of the study information | 2017/01/10 |
| Last modified on | 2023/01/14 10:14:34 |
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Basic information
Public title
The effect of inhaled bronchodilators on surgery for lung cancer surgery in patients with chronic obstructive lung disease; multicenter study
Acronym
The effect of inhaled bronchodilators on surgery for lung cancer surgery in patients with chronic obstructive lung disease
Scientific Title
The effect of inhaled bronchodilators on surgery for lung cancer surgery in patients with chronic obstructive lung disease; multicenter study
Scientific Title:Acronym
The effect of inhaled bronchodilators on surgery for lung cancer surgery in patients with chronic obstructive lung disease
Region
| Japan |
Condition
Condition
Primary lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the effect of inhaled bronchodilators on surgery for primary lung cancer in patients with chronic obstructive lung disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of cardiopulmonary complications within 30 days after surgery
Key secondary outcomes
1) Improvement of pulmonary function before and after inhalation of bronchodilators
2) Rate of postoperative coplications exclusing cardiopulmonary complications
3) Pulmonary function 1 year after surgery
4) 5-year survival rate
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. Clinically suspected primaruy lung cancer
2. FEV1/FVC<0.7 assessed by spirometry
3. Resectable cancer lesion by surgery less than single lobectomy
4. Patients stopping smoking 1 month before case registration
5. Adequate organ function tolerable for the general anesthesia
6. Capable of inhalation
7. Age of 20years or older
8. ECOG performance status 0-1
9. Written informed consent to participate
Key exclusion criteria
1. Previously treated for COPD or bronchial asthma
2. Patients with past pulmonary resection
3. History of active infection
4. Patients with psychiatric disease
5. Patients who are judged inappropriate to entry this study by physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Shintani |
Organization
Osaka University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
565-0871
Address
2-2-15 Yamadaoka, Suita, Osaka
TEL
0668793152
yshintani@thoracic.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Shintani |
Organization
Osaka University Graduate School of Medicine
Division name
General Thoracic Surgery
Zip code
5650871
Address
2-2-L5, Yamadaoka, Suita, Osaka, Japan
TEL
0668793152
Homepage URL
http://www.thoracic.med.osaka-u.ac.jp/jp/
yshintani@thoracic.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
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
Thoracic Surgery Study Group of Osaka University (TSSGO)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Center for Translational Research Osaka University Hospital
Address
2-2, Yamadaoka, Suita, Osaka, Japan
Tel
06-6210-8290
rinri@hp-crc.med.osaka-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
近畿大学医学部奈良病院市立（奈良県）
吹田市民病院（大阪府）
JCHO大阪病院（大阪府）
市立豊中病院（大阪府）
りんくう総合医療センター（大阪府）
国立病院機構大阪医療センター（大阪府）
箕面市立病院（大阪府）
大阪警察病院（大阪府）
八尾市立病院（大阪府）
国立病院機構近畿中央胸部疾患センター（大阪府）
公立学校共済組合近畿中央病院（兵庫県）
東大阪市立総合病院（大阪府）
大阪府立呼吸器アレルギー医療センター（大阪府）
大阪府立成人病センター（大阪府）
堺市立総合医療センター（大阪府）
西宮市立中央病院（兵庫県）
大阪府立急性期・総合医療センター（大阪府）
宝塚市立病院（兵庫県）
KKR大手前病院（大阪府）
星ケ丘医療センター（大阪府）
国立病院機構刀根山病院（大阪府）
徳洲会吹田病院（大阪府）
結核予防会大阪病院（大阪府）
日本生命済生会日生病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preoperative information, Operative information, postoperative complication
Management information
Registered date
| 2017 | Year | 01 | Month | 09 | Day |
Last modified on
| 2023 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029446
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
