Assisted-VATS Sleeve Lobectomy for Non-small Cell Lung Cancer

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00997724
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Duration (Months): 179
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Procedure: a-VATS	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer
• Study Start Date: Feb 1, 1996
• Anticipated Primary Completion Date: Jan 1, 2010
• Anticipated Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm

Intervention/Treatment

Experimental: a-VATS Patients with NSCLC underwent assisted-VATS sleeve lobectomy with bronchoplasty.

Procedure: a-VATS; 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: assisted-VATS (video-assisted thoracoscopic surgery)

Outcome Measures

Primary Outcome Measures

1. 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). [3 months]

Secondary Outcome Measures

1. To evaluate the intraoperative(surgical duration, estimated blood loss), postoperative variables(mortality, morbidity, chest tube drainage duration, hospital stay), and 5-year survival rates. [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong	China	510120

Sponsors and Collaborators

• The First Affiliated Hospital of Guangzhou Medical University

Investigators

• Study Director: Jianxing He, MD,FACS, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00997724
• Other Study ID Numbers: FAHG96016
• First Posted: Oct 19, 2009
• Last Update Posted: Jan 5, 2010
• Last Verified: Oct 1, 2009

• Keywords provided by , ,: assisted-VATS (video-assisted thoracoscopic surgery); sleeve lobectomy; bronchoplasty
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jan 5, 2010