Safety and Results of Thoracoscopic Lobectomy Using Thoracic Epidural Anesthesia Versus GA for Lung Cancer Patients
Lung cancer is the leading cause of cancer death in Taiwan. Traditionally, open thoracotomy
has been the standard approach for lung cancer surgery, including lobectomy and
pneumonectomy. With the advance of thoracoscopic technique, thoracoscopic lobectomy has
emerged as a reasonable option for the management of early-stage non-small cell lung cancer
(NSCLC), and is supported by evidence-based treatment guidelines. Advantages of
thoracoscopic lobectomy compared with thoracotomy include less postoperative pain, shorter
hospitalization, and decreased postoperative pulmonary complications.
Traditionally, general anesthesia (GA) with one-lung ventilation using double-lumen
endotracheal intubation has been considered mandatory in both open and thoracoscopic
surgery. However, adverse effects of GA may occur after the operation, including
ventilator-induced lung injury, impaired cardiac performance, postoperative nausea and
vomiting, and residual neuromuscular blockade.
In order to reduce the adverse effects of GA, thoracic epidural anesthesia (TEA) has been
recently employed to perform awake thoracic surgery procedures including coronary artery
bypass, management of pneumothorax, resection of pulmonary nodules and solitary metastases,
lung volume reduction (LVR), and even transsternal thymectomy. The results achieved in these
early series have been encouraging. In Taiwan, awake thoracic surgery has also been
performed at Taipei Veteran General Hospital in a high risk patient with satisfactory
results.
The role of TEA in thoracoscopic lobectomy is rarely investigated. There is a report showed
that lobectomy using TEA is safe and feasible, although only 3 cases were reported [13]. In
our hospital, we also performed 6 thoracoscopic lobectomy using TEA between August and
October, 2009 with satisfactory results. Until now, the safety and effects of TEA in
thoracoscopic lobectomy has been unclear and comparison between TEA and GA has never been
performed. We hypothesize that thoracoscopic lobectomy using TEA will be associated with a
comparable oncological results, lower cardiopulmonary complications, and shorter intensive
care unit (ICU) and hospital stays. To this end, we will compare safety and results of
thoracoscopic lobectomy using thoracic epidural anesthesia versus GA for lung cancer
patients.
This study will be performed at National Taiwan University Hospital. A total of 100 patients
will be included (50 patients in each arm).
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparing the safety after intervention of each group.
Comparing the complication and morbidity after intervention of each group
1 month
Yes
Jin-Shing Chen, MD, PhD
Study Chair
National Taiwan University Hospital
Taiwan: Department of Health
200911022R
NCT01533233
January 2010
December 2012
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