An interventional study of Segmentectomy and Lobectomy in Lung Adenocarcinoma, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Recruiting at 14 sites in China. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Not applicable, Interventional, and Treatment
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.
303 studies on the registry are indexed under Adenocarcinoma of Lung; 78 are open to participants now.
This study's planned enrollment of 690 is above the median of 63 across 212 interventional studies indexed under Adenocarcinoma of Lung.
Browse Adenocarcinoma of Lung studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.
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Exclusion Criteria:
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 after a comprehensive evaluation. As with lobectomy, 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 in the same manner as with lobectomy. When lymph node metastasis is present or resection margin is not cancer-free, the surgical procedure must be converted to a lobectomy.
Procedure: Segmentectomy
lobectomy 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 intraoperatively. 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.
Procedure: Lobectomy
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.
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
Perioperative morbidity or mortality
Any intraoperative and postoperative complications related to the surgery.
Time frame: 1 month
Plan to share: No
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Shanghai Pulmonary Hospital, Shanghai, China