Lung cancer, thoracic malignant diseases (metastatic tumors due to breast cancer, colon cancer, and other malignancies), and benign pulmonary tumors
Conditions
Interventions
1)Non-obstructive airflow group (normal pulmonary function group). One is group of glycopyrronium and indacaterol (LAMA/LABA) without glaucoma, prostatomegaly, and dysuria, after randamization of the
70%, GOLD-I, II, III). One is group of glycopyrronium and indacaterol (LAMA/LABA) without glaucoma, prostatomegaly, and dysuria. The other group of indacaterol (LABA) with glaucoma, prostatomegaly, an
Sponsors
University of Miyazaki Hospital Department of Surgery II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)wedge resection, lobectomy, peumonectomy, with video-assisted thoracic surgery and/or open thoracotomy 2)pulmonary emphysematous disease, COPD, untreated patient with flow-obstructive disease 3)no smoking patients (past smoker, current smoker, non-smoker) 4)toleratable patient for lung resection with normal or decreased lung function 5)interstitial pneumonia 6)emphysematous changes in lung field by CT-images 7)no complication of viable double cancers 8)Performance status 0-2 (Eastern Cooperative Oncology Group) 9)organ function before 2 weeks. WBC>=4,000/mm3, Hemoglobin>=9.0g/dl, Platelet>=100,000/mm3, AST<=100IU/L, ALT<=100IU/L, Total-bil<=1.5 mg/dl, Serum creatinin<=1.5mg/dl (Ccr>=45ml/min), Urine protein<=1+, arterial blood gas >=60 Torr(or > =SPO2 90% 10)Informed consent(document) 11)expected survival >= 3 months 12)Informed consent for clinical trial (document) 13)based on the preoperative examination and on the above criteria from 1) to 12), available and bearable for general anesthesia, video-assisted thoracic surgery or open thoracotomy, and lobectomy.
Exclusion criteria
Exclusion criteria: 1)closed angle glaucoma 2)prostatomegaly and dysuria 3)past medical history of hypersensitivity, allergy 4)bronchodilator treatment except for LAMA/LABA and LABA 5)under treatment of Bronchial asthma 6)severe hypokalemia 7)atrial fibrillation 8)Others. Patients judged for inappropriation by attending physician or lead principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Pre- and postoperative pulmonary function test (FVC, FEV1, inspiratory capacity, flow volume curve) 2)Changed rates of actual FEV1 value (pre- and postoperative values),(COPD-group and non-obstructive groups with and without intervention of bronchodilators) 3)Improvement of the residual lung volume by analysis of computed tomographic volumetry (changed and expanded rates) 4)Changes of QOL 5)'Lung age' | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Changes of QOL 2)Safety, adverse event(NCI-CTCAE, ver 4.0) 3)Postoperative complications 4)Analysis of free-radical productives (oxidative stress and anti-oxidative capacity) 5)Changes of postoperative intrapleural pressure 6)Changes based on the resected location (Lt. vs Rt., Upper lobe vs middle lobe vs lower lobe) | — |
Countries
Japan
Contacts
Public ContactTakanori AYABE
University of Miyazaki, Faculty of Medicine Depatment of Surgery II
Outcome results
None listed