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A prospective observational study of the surgery for lung cancer in patients with low pulmonary function

A prospective observational study of the surgery for lung cancer in patients with low pulmonary function - A prospective observational study of the surgery for lung cancer in patients with low pulmonary function

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000013233
Enrollment
50
Registered
2014-02-24
Start date
2014-02-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary lung cancer, Chronic Obstructive Lung Disease (COPD)

Interventions

None listed

Sponsors

Yokohama City University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Clinically suspected primary lung cancer. 2) Postbronchodilator FEV1/FVC (forced expiratory volume in 1s/forced vital capacity) < 0.70 assessed by spirometry. 3) Resectable cancer lesion by surgery less than single lobectomy. 4) Without previously treatment for bronchial asthma. 5) No past pulmonary resection excluding wedge resection. 6) Patients stopping smoking at the time of giving the consent to this study. 7) Adequate organ function tolerable for the general anesthesia. 8) Age of 20 years or older. 9) ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0, 1, 2. 10) Written informed consent to participate.

Exclusion criteria

Exclusion criteria: 1) Median sternotomy. 2) Combined resection of the chest wall excluding parietal pleura excision. 3) History of active infection. 4) Active double cancer within 5 years of disease-free interval, except for curable lesions like carcinoma in situ and mucosal cancer. 5) Patients with glaucoma. 6) Patients with dysuria. 7) History of hypersensitivity to atropine or drugs similar to atropine. 8) Patients with interstitial pneumonia or pulmonary fibrosis. 9) Patients with arrhythmia requiring antiarrhythmic continuously. 10) Patients with thyropathy. 11) Patients with renal dysfunction needs blood purification therapy. 12) Patients with psychiatric disease. 13) Patients requiring systemic steroids medication. 14) Patients with uncontrolled diabetes mellitus. 15) Patients with uncontrolled hypertension. 16) Current or previous within the last 6 months history of severe heart diseases, cerebrovascular disease. 17) The pregnant and lactating female , female who has possibility of the pregnancy. 18) Patients who were judged inappropriate to entry this study by physician.

Design outcomes

Primary

MeasureTime frame
1- year overall survival

Secondary

MeasureTime frame
1)Rate of cardiopulmonary complications after surgery 2)Detail of cardiopulmonary complications after surgery 3)Rate of post operative complications excluding cardiopulmonary complications 4)Improvement of pulmonary function before and after using of drugs for COPD 5)Evaluation of the postoperative complications using the Clavien-Dindo classification 6)3-years overall survival 7)Rate of adverse events 8)Evaluation of postoperative compliance

Countries

Japan

Contacts

Public ContactTeppei Nishii

Yokohama City University Medical Center Thoracic Surgery

nteppei@yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026