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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01533233
First received: February 15, 2011
Last updated: October 27, 2013
Last verified: October 2013
  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: thoracoscopic lobectomy and mediastinal lymph node dissection
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 Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients.

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nonintubated anesthesia
Thoracoscopic lobectomy using nonintubated anesthesia
Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection
Other Name: VATS lobectomy
Active Comparator: intubated general anesthesia
Thoracoscopic lobectomy using intubated general anesthesia
Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection
Other Name: VATS lobectomy

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).

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533233

Contacts
Contact: Jin-Shing Chen, MD, PhD 886-2-23123456 ext 65178 chenjs@ntu.edu.tw

Locations
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: Jin-Shing Chen, MD, PhD         
Sub-Investigator: Ya-Jung Cheng, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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: October 27, 2013
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 July 22, 2014