This study aims to evaluate the non-inferiority in recurrence-free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype negative by intraoperative frozen sections.
At present, the technology of intraoperative frozen section has gradually matured, which can diagnose the benign and malignant tumors and guide the resection strategy for peripheral small-sized lung adenocarcinoma. Travis et al. reported high specificity of intraoperative frozen section in the identification of micropapillary components, confirming that intraoperative frozen section may guide the selection of surgical procedures. However, there is still little evidence weather segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the non-inferiority in recurrence free survival and overall survival of segmentectomy compared with lobectomy in patients with lung adenocarcinoma (≤ 2 cm) not including micropapillary components.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
690
Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
Anhui Chest Hospital
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China
recurrence-free survival rate
Recurrence-free survival (RFS) was defined as the time from surgery until recurrence or death from any cause
Time frame: 5 year
overall survival
Overall survival (OS) was defined as the time from surgery until death from any cause
Time frame: 5 year
Post-operative respiratory function
The post-operative respiratory function will be evaluated by FEV1% and FVC.
Time frame: 6 months
Operation time
The surgery time in both groups.
Time frame: 24 hours
Blood loss
Intraoperative blood loss in total.
Time frame: 24 hours
Incidence of operative complications
Any intraoperative complications related to the surgery.
Time frame: 1 month
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Nanyang Central Hospital
Nanyang, Henan, China
RECRUITINGThe Sixth People's Hospital of Nantong
Nantong, Jiangsu, China
RECRUITINGAffiliated Hospital of Nantong University
Nantong, Jiangsu, China
RECRUITINGAffiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
RECRUITINGYancheng First People's Hospital
Yancheng, Jiangsu, China
RECRUITINGShandong Public Health Clinical Center
Jinan, Shandong, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGHuadong Hospital
Shanghai, Shanghai Municipality, China
RECRUITING...and 4 more locations