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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
thoracoscopic lobectomy and mediastinal lymph node dissection
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring thoracoscopy, lung cancer, lobectomy, epidural anesthesia

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

nonintubated anesthesia

intubated general anesthesia

Arm Description

Thoracoscopic lobectomy using nonintubated anesthesia

Thoracoscopic lobectomy using intubated general anesthesia

Outcomes

Primary Outcome Measures

Comparing the safety after intervention of each group.
Comparing the complication and morbidity after intervention of each group

Secondary Outcome Measures

Short-term outcome
including ICU stay, period of ventilator use, hospital stay, number of days with chest drainage, adverse events, etc.
Oncological outcome
Number of LN dissection and overall survival after the operation

Full Information

First Posted
February 15, 2011
Last Updated
October 27, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01533233
Brief Title
Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients
Official Title
Safety and Results of Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
thoracoscopy, lung cancer, lobectomy, epidural anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nonintubated anesthesia
Arm Type
Experimental
Arm Description
Thoracoscopic lobectomy using nonintubated anesthesia
Arm Title
intubated general anesthesia
Arm Type
Active Comparator
Arm Description
Thoracoscopic lobectomy using intubated general anesthesia
Intervention Type
Procedure
Intervention Name(s)
thoracoscopic lobectomy and mediastinal lymph node dissection
Other Intervention Name(s)
VATS lobectomy
Primary Outcome Measure Information:
Title
Comparing the safety after intervention of each group.
Description
Comparing the complication and morbidity after intervention of each group
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Short-term outcome
Description
including ICU stay, period of ventilator use, hospital stay, number of days with chest drainage, adverse events, etc.
Time Frame
one month
Title
Oncological outcome
Description
Number of LN dissection and overall survival after the operation
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Shing Chen, MD, PhD
Phone
886-2-23123456
Ext
65178
Email
chenjs@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
Phone
886-2-23123456
Ext
65178
Email
chenjs@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Jin-Shing Chen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Ya-Jung Cheng, MD, PhD

12. IPD Sharing Statement

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

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