Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients

Lung Cancer Clinical Trial

Official title:

Safety and Results of Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01533233
• Other study ID #: 200911022R
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 15, 2011
• Last updated: October 27, 2013
• Start date: February 2011
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: Jin-Shing Chen, MD, PhD
• Phone: 886-2-23123456
• Email: chenjs[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

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, nonintubated anesthesia has been recently employed to perform 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, nonintubated thoracic surgery has also been performed at Taipei Veteran General Hospital in a high risk patient with satisfactory results.

The role of nonintubated anesthesia in thoracoscopic lobectomy is rarely investigated. There is a report showed that lobectomy using nonintubated anesthesia is safe and feasible, although only 3 cases were reported [13]. In our hospital, we also performed 6 thoracoscopic lobectomy using nonintubated anesthesia between August and October, 2009 with satisfactory results. Until now, the safety and effects of nonintubated anesthesia in thoracoscopic lobectomy has been unclear and comparison between nonintubated and intubated general anesthesia has never been reported. We hypothesize that nonintubated thoracoscopic lobectomy 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 nonintubated anesthesia versus intubated general anesthesia 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Procedure:
• thoracoscopic lobectomy and mediastinal lymph node dissection

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing the safety after intervention of each group.	Comparing the complication and morbidity after intervention of each group	1 month	Yes
Secondary	Short-term outcome	including ICU stay, period of ventilator use, hospital stay, number of days with chest drainage, adverse events, etc.	one month	Yes
Secondary	Oncological outcome	Number of LN dissection and overall survival after the operation	5 years	No