Thoracoscopic Lobectomy Using Thoracic Epidural Anesthesia Versus General Anesthesia for Lung Cancer Patients
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Purpose
The purpose of this study is to study the safety and results of thoracoscopic lobectomy using non-intubated thoracic epidural anesthesia versus intubated general anesthesia for lung cancer patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Procedure: non-intubated anesthesia Procedure: general anesthesia |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Results of Thoracoscopic Lobectomy Using Thoracic Epidural Anesthesia Versus GA for Lung Cancer Patients |
- Comparing the safety after intervention of each group. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]Comparing the complication and morbidity after intervention of each group
- Short-term outcome [ Time Frame: one month ] [ Designated as safety issue: Yes ]including ICU stay, period of ventilator use, hospital stay, number of days with chest drainage, adverse events, etc.
- Oncological outcome [ Time Frame: 5 years ] [ Designated as safety issue: No ]Number of LN dissection and overall survival after the operation
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: non-intubated epidural anesthesia
Thoracoscopic lobectomy using non-intubated epidural anesthesia
|
Procedure: non-intubated anesthesia
Thoracoscopic lobectomy using non-intubated thoracic epidural anesthesia
Other Name: Non-intubated VATS
|
|
Active Comparator: intubated general anesthesia
Thoracoscopic lobectomy using intubated general anesthesia
|
Procedure: general anesthesia
Thoracoscopic lobectomy using intubated general anesthesia
Other Name: traditional VATS
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 25 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non-small cell lung cancer with clinical staging of I or II for whom thoracoscopic lobectomy is feasible.
- Age between 25 and 80 years old
- Tumor size < 5 cm without chest wall, diaphragm, or main bronchus invasion
- Predicted FEV 1.0 > 60% or FEV1.0 > 1.5L
Organ Function Requirements:
- Adequate hematological function (ANC > 1.5 x 109/L, platelets > 100 x 109/L)
- PT, PTT<1.5X
- Written inform consent
Exclusion Criteria:
- Failed thoracic epidural catheter insertion
- A history of previous epidural catheter insertion or ipsilateral thoracic operation
- Signs of intrapleural adhesions
- Pregnant or lactation female
- ASA score greater than 3
- Unfavorable airway or spinal anatomy judged by anesthesiologist
- Sleep apnea
Contacts and Locations| Contact: Jin-Shing Chen, MD, PhD | 886-2-23123456 ext 65178 | chenjs@ntu.edu.tw |
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 100 | |
| Contact: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 65178 chenjs@ntu.edu.tw | |
| Principal Investigator: Yung-Chie Lee, MD, PhD | |
| Sub-Investigator: Jin-Shing Chen, MD, PhD | |
| Study Chair: | Jin-Shing Chen, MD, PhD | National Taiwan University Hospital |
More Information
No publications provided
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT01533233 History of Changes |
| Other Study ID Numbers: | 200911022R |
| Study First Received: | February 15, 2011 |
| Last Updated: | December 13, 2012 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Taiwan University Hospital:
|
thoracoscopy lung cancer lobectomy epidural anesthesia |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013