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Safety and Results of Thoracoscopic Lobectomy Using Thoracic Epidural Anesthesia Versus GA for Lung Cancer Patients

Phase 1/Phase 2
25 Years
80 Years
Open (Enrolling)
Lung Cancer

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Trial Information

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

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

This study will be performed at National Taiwan University Hospital. A total of 100 patients
will be included (50 patients in each arm).

Inclusion Criteria:

1. Non-small cell lung cancer with clinical staging of I or II for whom thoracoscopic
lobectomy is feasible.

2. Age between 25 and 80 years old

3. Tumor size < 5 cm without chest wall, diaphragm, or main bronchus invasion

4. Predicted FEV 1.0 > 60% or FEV1.0 > 1.5L

5. Organ Function Requirements:

- Adequate hematological function (ANC > 1.5 x 109/L, platelets > 100 x 109/L)

- PT, PTT<1.5X

6. Written inform consent

Exclusion Criteria:

1. Failed thoracic epidural catheter insertion

2. A history of previous epidural catheter insertion or ipsilateral thoracic operation

3. Signs of intrapleural adhesions

4. Pregnant or lactation female

5. ASA score greater than 3

6. Unfavorable airway or spinal anatomy judged by anesthesiologist

7. Sleep apnea

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Comparing the safety after intervention of each group.

Outcome Description:

Comparing the complication and morbidity after intervention of each group

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Jin-Shing Chen, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

January 2010

Completion Date:

December 2012

Related Keywords:

  • Lung Cancer
  • thoracoscopy
  • lung cancer
  • lobectomy
  • epidural anesthesia
  • Lung Neoplasms