Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.
The study is a non-inferior statistical comparison, with 681 patients in each group. The anticipated enroll period is 3 years, followed by observation period of 5 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,362
Systematic hilar and mediastinal lymph node dissection.
Mediastinal lymph node is spared in this group.
Ethics review board of Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGOverall survival
Overall survival is defined as days from randomization to death from any cause, and it was censored at the last day when the patient was alive.
Time frame: 5 years
Relapse-free survival
RFS time is defined as days from randomization to relapse or death for any patient.
Time frame: 5 years
Proportion of local recurrence
Proportion of local recurrence in any kind of recurrences.
Time frame: 5 years
Duration of hospitalization
Duration of hospitalization around surgery.
Time frame: 1-60 days
Duration of chest drainage tube placement
Duration of chest drainage tube placement after surgery.
Time frame: 1-60 days
Operation time
Time duration of surgery.
Time frame: 20-180 minutes.
Blood loss
Blood loss during surgery.
Time frame: 1-60 days
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