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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Segmentectomy | Experimental | 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. |
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| Lobectomy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Segmentectomy | 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. |
| 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 | Overall survival (OS) was defined as the time from surgery until death from any cause | 5 year |
| Post-operative respiratory function | The post-operative respiratory function will be evaluated by FEV1% and FVC. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hang Su | Contact | +86 13917810850 | dreamsuhang@163.com | |
| Chang Chen, MD, PhD | Contact | +86 021-65115006 | chenthoracic@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Chen, MD, PhD | Shanghai Pulmonary Hospital, School of Medicine, Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hospital | Recruiting | Hefei | Anhui | 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 |
| D038481 | Anterior Temporal Lobectomy |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
| D019635 | Neurosurgical Procedures |
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segmentectomy group versus lobectomy group
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no masking
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| Lobectomy | 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. |
|
| 6 months |
| Operation time | The surgery time in both groups. | 24 hours |
| Blood loss | Intraoperative blood loss in total. | 24 hours |
| Perioperative morbidity or mortality | Any intraoperative and postoperative complications related to the surgery. | 1 month |
| The First Affiliated Hospital of University of Science and Technology of China | Recruiting | Hefei | Anhui | China |
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| Nanyang Central Hospital | Recruiting | Nanyang | Henan | China |
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| The Sixth People's Hospital of Nantong | Recruiting | Nantong | Jiangsu | 216002 | China |
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| Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | 226001 | China |
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| Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
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| Yancheng First People's Hospital | Recruiting | Yancheng | Jiangsu | China |
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| Shandong Public Health Clinical Center | Recruiting | Jinan | Shandong | China |
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| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| Huadong Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
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| Huzhou Central Hospital | Recruiting | Huzhou | Zhejiang | China |
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| Ningbo First Hospital | Recruiting | Ningbo | Zhejiang | China |
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| Ningbo No.2 Hospital | Recruiting | Ningbo | Zhejiang | China |
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| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |