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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025587
Receipt No. 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 2017/08/06

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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 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Shintani
Organization Osaka University Graduate School of Medicine
Division name General Thoracic Surgery
Zip code
Address 2-2-L5, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3152
Email yshintani@thoracic.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Shintani
Organization Osaka University Graduate School of Medicine
Division name General Thoracic Surgery
Zip code
Address 2-2-L5, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3152
Homepage URL
Email yshintani@thoracic.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 01 Month 10 Day
Last follow-up date
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
2017 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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