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.
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 lung-cancer
Started Feb 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 29, 2013
October 1, 2013
3.6 years
February 15, 2011
October 27, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparing the safety after intervention of each group.
Comparing the complication and morbidity after intervention of each group
1 month
Secondary Outcomes (2)
Short-term outcome
one month
Oncological outcome
5 years
Study Arms (2)
nonintubated anesthesia
EXPERIMENTALThoracoscopic lobectomy using nonintubated anesthesia
intubated general anesthesia
ACTIVE COMPARATORThoracoscopic lobectomy using intubated general anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jin-Shing Chen, MD, PhD
National Taiwan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 15, 2012
Study Start
February 1, 2011
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
October 29, 2013
Record last verified: 2013-10