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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00997724
Acronym
VATS
Enrollment
100
Registered
2009-10-19
Start date
1996-02-29
Completion date
2011-01-31
Last updated
2010-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

assisted-VATS (video-assisted thoracoscopic surgery), sleeve lobectomy, bronchoplasty

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.

Interventions

PROCEDUREa-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.

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026