Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer (VATS)
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
a-VATS
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring assisted-VATS (video-assisted thoracoscopic surgery), sleeve lobectomy, bronchoplasty
Eligibility Criteria
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
Sites / Locations
- Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
a-VATS
Arm Description
Patients with NSCLC underwent assisted-VATS sleeve lobectomy with bronchoplasty.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
To evaluate the intraoperative(surgical duration, estimated blood loss), postoperative variables(mortality, morbidity, chest tube drainage duration, hospital stay), and 5-year survival rates.
Full Information
NCT ID
NCT00997724
First Posted
October 18, 2009
Last Updated
January 4, 2010
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT00997724
Brief Title
Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer
Acronym
VATS
Official Title
Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 1996 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
assisted-VATS (video-assisted thoracoscopic surgery), sleeve lobectomy, bronchoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
a-VATS
Arm Type
Experimental
Arm Description
Patients with NSCLC underwent assisted-VATS sleeve lobectomy with bronchoplasty.
Intervention Type
Procedure
Intervention Name(s)
a-VATS
Other Intervention Name(s)
assisted-VATS (video-assisted thoracoscopic surgery)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxing He, MD,FACS
Organizational Affiliation
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
21298520
Citation
He J, Shao W, Cao C, Yan TD, Wang D, Xiong X, Yin W, Xu X, Huang J. Long-term outcome of hybrid surgical approach of video-assisted minithoracotomy sleeve lobectomy for non-small-cell lung cancer. Surg Endosc. 2011 Aug;25(8):2509-15. doi: 10.1007/s00464-011-1576-6. Epub 2011 Feb 7.
Results Reference
derived
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Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer
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