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This study aims to evaluate the superiority in recurrence-free survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma ≤ 2 cm with micropapillary and solid subtype positive 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 whether segmentectomy is appropriate for invasive adenocarcinoma without micropapillary patterns. This prospective and multi-center study was aimed to evaluate the superiority in recurrence free survival and overall survival of lobectomy compared with segmentectomy in patients with lung adenocarcinoma (≤ 2 cm) containing positive micropapillary components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lobectomy with systemic lymph node dissection | 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. |
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| Segmentectomy with systemic lymph node dissection | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lobectomy with systemic lymph node dissection | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence-free survival rate | Recurrence-free survival (RFS) was defined as the time from surgery until recurrence or death from any cause | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival rate | Overall survival (OS) was defined as the time from surgery until death from any cause | 5 year |
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Inclusion Criteria:
Exclusion Criteria:
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clinical stage IA patients with Lung Adenocarcinoma ≤ 2cm as well as micropapillary and solid Subtype positive (>5%) by frozen sections
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Long Xu, MD | Contact | 15801783037 | xulong1228@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Yangpu | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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| Segmentectomy with systemic lymph node dissection | Procedure | 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. |
|
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |