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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Cancer
• Intervention / Treatment: Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection

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, 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).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Principal Investigator: Jin-Shing Chen, MD, PhD
    • Sub-Investigator: Ya-Jung Cheng, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nonintubated anesthesia; Thoracoscopic lobectomy using nonintubated anesthesia	Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection; Other Names: VATS lobectomy
Active Comparator: intubated general anesthesia; Thoracoscopic lobectomy using intubated general anesthesia	Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection; Other Names: VATS lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the safety after intervention of each group.	Comparing the complication and morbidity after intervention of each group	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term outcome	including ICU stay, period of ventilator use, hospital stay, number of days with chest drainage, adverse events, etc.	one month
Oncological outcome	Number of LN dissection and overall survival after the operation	5 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Jin-Shing Chen, MD, PhD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: February 15, 2011
• First Submitted That Met QC Criteria: February 11, 2012
• First Posted (Estimate): February 15, 2012

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: October 27, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: lung cancer; thoracoscopy; lobectomy; epidural anesthesia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 200911022R