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

NCT ID: NCT00997724

Last Updated: 2010-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-02-29
• Study Completion Date: 2011-01-31

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.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

a-VATS

Patients with NSCLC underwent assisted-VATS sleeve lobectomy with bronchoplasty.

Group Type: EXPERIMENTAL

a-VATS

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

assisted-VATS (video-assisted thoracoscopic surgery)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

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

Principal Investigators

Jianxing He, MD,FACS

Role: STUDY_DIRECTOR

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

Locations

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

Guangzhou, Guangdong, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 21298520 (View on PubMed)

Other Identifiers

FAHG96016

Identifier Type: -

Identifier Source: org_study_id