Lung CancerPhase 1/2NCT01533233
Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients
A Phase 1/2 study testing thoracoscopic lobectomy and mediastinal lymph node dissection in people with Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- thoracoscopic lobectomy and mediastinal lymph node dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Dec 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 100
Jin-Shing Chen, MD, PhD, 886-2-23123456 ext. 65178, chenjs@ntu.edu.tw
Jin-Shing Chen, MD, PhD
About this study
Official title: 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.
Read the 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).
- Conditions
- Lung Cancer
- Being tested
- thoracoscopic lobectomy and mediastinal lymph node dissection
- Keywords
- thoracoscopy, lung cancer, lobectomy, epidural anesthesia
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracoscopic lobectomy and mediastinal lymph node dissectionProcedure or surgery
Also called VATS lobectomy
| Study group | Role | What they receive |
|---|---|---|
| nonintubated anesthesia | Experimental | Thoracoscopic lobectomy using nonintubated anesthesia Receives: Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection |
| intubated general anesthesia | Active comparator | Thoracoscopic lobectomy using intubated general anesthesia Receives: Procedure: thoracoscopic lobectomy and mediastinal lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the safety after intervention of each group.
Comparing the complication and morbidity after intervention of each group
Measured: 1 month
Secondary outcomes (2)
Short-term outcome
including ICU stay, period of ventilator use, hospital stay, number of days with chest drainage, adverse events, etc.
Measured: one month
Oncological outcome
Number of LN dissection and overall survival after the operation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2012 (estimated)
- Study startFeb 2011
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin-Shing Chen, MD, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01533233
- Sponsor's protocol ID
- 200911022R
- Status last verified
- Oct 2013
- First submitted
- 15 Feb 2011
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Results of Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients.
- ClinicalTrials.gov ID
- NCT01533233
- Acronym / sponsor ID
- 200911022R
- Conditions
- Lung Cancer
- Keywords
- thoracoscopy, lung cancer, lobectomy, epidural anesthesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nonintubated anesthesia | Experimental | Procedure: thoracoscopic lobectomy and mediastinal lymph node dissectionThoracoscopic lobectomy using nonintubated anesthesia |
| intubated general anesthesia | Active comparator | Procedure: thoracoscopic lobectomy and mediastinal lymph node dissectionThoracoscopic lobectomy using intubated general anesthesia |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thoracoscopic lobectomy and mediastinal lymph node dissectionAlso: VATS lobectomy | Procedure or surgery | intubated general anesthesia, nonintubated anesthesia |
Primary outcome
Comparing the safety after intervention of each group.
Time frame: 1 month
Comparing the complication and morbidity after intervention of each group
2 secondary outcomes
Short-term outcome
Time frame: one month
Oncological outcome
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin-Shing Chen, MD, PhD study chair
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing thoracoscopic lobectomy and mediastinal lymph node dissection in people with Lung Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin-Shing Chen, MD, PhD (886-2-23123456 ext. 65178, chenjs@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing the safety after intervention of each group. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.