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

Guangzhou Medical University

Status and phase

Unknown

Phase 2

Conditions

Non-small Cell Lung Cancer

Treatments

Procedure: a-VATS

Study type

Interventional

Funder types

Other

Identifiers

NCT00997724

FAHG96016

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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