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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT00997724
First received: October 18, 2009
Last updated: January 4, 2010
Last verified: October 2009
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Procedure: a-VATS
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility of Assisted-VATS(Video-Assisted Thoracoscopic Surgery) Sleeve Lobectomy for Non-small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

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). [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: February 1996
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: assisted-VATS (video-assisted thoracoscopic surgery)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00997724

Locations
China, Guangdong
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
  More Information

No publications provided by The First Affiliated Hospital of Guangzhou Medical University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The First Affiliated Hospital of Guangzhou Medical College, Department of Cardiothoracic Surgery, the First Affiliated Hospital of Guangzhou Medical College
ClinicalTrials.gov Identifier: NCT00997724     History of Changes
Other Study ID Numbers: FAHG96016
Study First Received: October 18, 2009
Last Updated: January 4, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
assisted-VATS (video-assisted thoracoscopic surgery)
sleeve lobectomy
bronchoplasty

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014