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Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer


Phase 2
18 Years
80 Years
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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).

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

Jianxing He, MD,FACS

Investigator Role:

Study Director

Investigator Affiliation:

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College

Authority:

China: Food and Drug Administration

Study ID:

FAHG96016

NCT ID:

NCT00997724

Start Date:

February 1996

Completion Date:

January 2011

Related Keywords:

  • Non-Small Cell Lung Cancer
  • assisted-VATS (video-assisted thoracoscopic surgery)
  • sleeve lobectomy
  • bronchoplasty
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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