- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00997724
Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer (VATS)
Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer
Study Overview
Detailed Description
Sleeve lobectomy is removal of a portion of a main stem bronchus in continuity with the adjacent lobe or bilobe followed by end-to-end bronchial anastomosis. The first reported bronchial sleeve resection was performed in 1947 at the Brompton Hospital in London, England, by Sir Clement Price Thomas. Whether sleeve resection is radical enough and indicated for patients who could tolerate pneumonectomy continues to be debated, although many recent reports have suggested that sleeve resection can achieve adequate curability rates. However, sleeve lobectomy has a definite role in the surgical management of lung cancer for patients whose pulmonary reserve is considered inadequate to permit pneumonectomy, and should be used anytime it is possible to achieve a margin-negative (R0) resection.
Although video-assisted thoracic surgery (VATS) is regarded as a minimally invasive procedure with good long-term survival results, many surgeons think that VATS is too complex and has too many technical limitations to be applied to bronchoplasty. Therefore, there are few reports in the literature of VATS bronchoplasty for lung cancer. The purpose of this study is to examine the feasibility of assisted-VATS (video-assisted thoracoscopic surgery) sleeve lobectomy for non-small cell lung cancer for non-small cell lung cancer. Success is defined as assisted-VATS sleeve lobectomy without conversion. If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer (Squamous, adenosquamous, large cell, or poorly differentiated)
- Patients with central tumors located at the origin of a lobar bronchus.
- ECOG performance status 0-1
- Hematopoietic: WBC at least 4,000/mm^3; Platelet count at least 100,000/mm^3
- Hepatic: Bilirubin normal; AST/ALT no greater than 1.5 times upper limit of normal (ULN); Alkaline phosphatase no greater than 2.5 times ULN
- Renal: Creatinine clearance greater than 60 ml/min
- Cardiovascular: Cardiac function normal
Exclusion Criteria:
- Severe complications or infections
- Pregnant or breast-feeding women
- Clinically significant heart disease
- Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: a-VATS
Patients with NSCLC underwent assisted-VATS sleeve lobectomy with bronchoplasty.
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In brief, general anesthesia with selective lung ventilation was performed with the use of a double-lumen endotracheal tube.
When postoperative mechanical ventilation was necessary, a standard endotracheal tube was substituted for the double-lumen tube.
Patients were placed in the lateral decubitus position.
Two thoracoports were placed in the sixth or seventh intercostal space (ICS) on the anterior axillary line and in the seventh or eighth ICS on the posterior axillary line; an anterolateral minithoracotomy (7 cm) was made in the fourth ICS for an upper lobectomy or in the fifth ICS for a middle or lower lobectomy.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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If success rate over 90%, assisted-VATS sleeve lobectomy is considered as feasible procedures for non-small cell lung cancer. (Success is defined as assisted-VATS sleeve lobectomy without conversion).
Time Frame: 3 months
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3 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To evaluate the intraoperative(surgical duration, estimated blood loss), postoperative variables(mortality, morbidity, chest tube drainage duration, hospital stay), and 5-year survival rates.
Time Frame: 3 months
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3 months
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Collaborators and Investigators
Investigators
- Study Director: Jianxing He, MD,FACS, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FAHG96016
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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