Esophageal cancer
Conditions
Interventions
Inhalation of tiotropium of 5 microgram, starting from 2 weeks before esophagectomy.
No inhalation of tiotropium.
Sponsors
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed esophageal cancer. 2) Resectable disease in preoperative evaluation. 3) Age of 20 years or older. 4) ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-1. 5) Esophagectomy with thoracic procedure 6) Postbronchodilator FEV1/FVC (forced expiratory volume in 1s/forced vital capacity) < 0.70 assessed by spirometry. 7) Patients stopping smoking for two weeks or more. 8) Capable of inhalation. 9) Adequate organ function tolerable for the general anesthesia. 10) Written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1) Comorbidities a) Previous history of thoracic surgery. b) Patients with glaucoma. c) Patients with prostatic hypertrophy. d) Patients with heart failure and/or atrial fibrillation. e) Previously treatment for chronic obstructive pulmonary disease (COPD) or bronchial asthma. f) Patients with active infection. 2) Total pharyngolaryngoesophagectomy, two staged esophagectomy, and reconstruction without gastric conduit. 3) Others a) Patients with psychiatric disease. b) Patients who were judged inappropriate to entry this study by physician in charge. c) Previous history of hypersensitivity to atropine or drugs similar to atropine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pneumonia within 30 days after esophagectomy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of cardiovascular complications within 30 days after esophagectomy 2) Incidence of any postoperative complications within 30 days after esophagectomy 3) FEV1% (pretreatment, preoperative, postoperative) 4) Walking distances in incremental shuttle walking test (pretreatment, preoperative, postoperative) 5) Incidence of adverse events 6) Mortality within 30 days after esophagectomy | — |
Countries
Japan
Contacts
Public ContactAkihiko Okamura
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Division of Esophageal Surgery, Department of Gastroenterological Surgery
Outcome results
None listed