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Video-assisted thoracic surgery versus open lobectomy for lung cancer: a randomized prospective trial

Phase 4
Recruiting
Conditions
lung cancer
pulmonary carcinoma
10029107
Registration Number
NL-OMON37381
Lead Sponsor
niversitair Medisch Centrum Sint Radboud
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
160
Inclusion Criteria

Patients selected by multidisciplinary oncologic team to undergo lobectomy
Non-small cell lung carcinoma, pathologically confirmed or strong suspicion based on imaging.
T1 or T2a (<= 5 cm) on computer tomography (CT).
Primary aim is lobectomy.
Tumor is not in close relation to central structures (main bronchus, pulmonary artery or pulmonary veins) and is surrounded by lung parenchym (based on CT).
Clinically staged N0 or N1 (lymfnodes), M0 (no distant metastasis) after clinical staging according to the current Dutch guideline (may 2011).

Exclusion Criteria

T2b, T3 or T4 tumor (7th guideline TNM classification NSCLC).
Mediastinal lymph node metastasis (N2, N3).
Distant metastasis (M1).
Previous thoracic surgery on same side.
Pneumonectomy as primary aim.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary endpoints are postoperative quality of life, number of dissected<br /><br>mediastinal lymph nodes for oncologic staging, hospital length of stay and<br /><br>overall costs. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints include procedural complication rates, pulmonary function<br /><br>and survival.</p><br>
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