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The purpose of this study is to evaluate whether the long-term outcome and safety of wedge resection are comparable to segmentectomy for the surgical treatment of early stage (IA) non-small cell lung cancer (NSCLC). Zhang et al. performed a meta-analysis of 53 studies and suggested that sublobectomy achieved a survival rate comparable to lobectomy in a selected population of patients with Stage I NSCLC. However, one critical question needs to be addressed, that is, does sublobectomy require segmentectomy or wedge resection? Cho et al. reported that, for pulmonary ground glass opacity (GGO) nodules (Stage IA NSCLC), wedge resection achieved a 5-year survival rate of 98.6% in the pure GGO group and 95.5% in the mixed GGO group. Cho et al. cautioned against performing wedge resection for mixed GGO nodules with GGO component ≤ 75%, due to the high recurrence rate. When radiology shows that the GGO component is ≥75%, pathology usually finds that the lesions are non-invasive. Therefore, these lesions are potential candidates for wedge resection. This randomized clinical trial is to assess whether wedge resection can be established as a standard treatment for Stage IA NSCLC with tumor size ≤ 2 cm and GGO component ≥ 75%.
Selection procedures: When a case meets the inclusion criteria and does not meet exclusion criteria, the research assistant of each research participating center will fill out the Eligibility Application Form and submit it to the Research Committee for reviewing whether the case is eligible for the trial. The following rules will be strictly applied:
Qualification of the responsible surgeons who participate in this study: the responsible surgeons who participate in this study shall meet the following qualifications: 1) at least have completed 20 cases of VATS segmentectomy; and 2) have passed the blind review of his/her video records of the surgery.
Criteria for confirming operation quality: for the case to be included in the analysis, the responsible surgeon shall submit the video or photo recordings of the surgery to the Research Committee for evaluation of the surgical procedures.
Rules for handling the excluded patients identified intraoperatively: if the responsible surgeon finds that the patient in operation meets the exclusion criteria, the case will be excluded and the surgeon will follow the routine clinical practice of the research participating center to decide subsequent treatments that are not specified in this study protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Wedge resection |
|
| Group B | Active Comparator | Segmentectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wedge resection | Procedure | A wedge resection is the surgical removal of the lung tumor with a small portion of the lung that surrounds the tumor. Hilar and mediastinal lymph nodes should be resected or sampled. |
| Measure | Description | Time Frame |
|---|---|---|
| 5-year Progression-Free-Survival | From date of the recruitment, assessed up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year Progression-Free-Survival | From date of the recruitment, assessed up to 36 months | |
| 5-year overall survival | From date of the recruitment, assessed up to 60 months | |
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Inclusion criteria:
Preoperative thin-section computed tomography (TSCT) will fulfill all of the following conditions:
Preoperative clinical staging: T1a-T1bN0M0 (according to UICC2017-8thTNM staging).
R0 resectable in segmentectomy and wedge resections plus mediastinal lymph node resection.
Aged 18 to 75 years old.
No prior chemotherapy or thoracic radiation therapy for any malignant diseases.
Preoperative FEV1.0>=1.0 L.
Performance status of ECOG 0 or 1.
Preoperative ASA scoring (American society of anesthesiology) class I -III.
Sufficient organ functions.
The patient agrees to participate in the trial and signs the informed consent form.
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hu Liao, M.D. | Contact | +86 28 85422494 | liaotiger_198653@163.com | |
| Liyan Chen, M.Sc. | Contact | +86 28 85422494 | lilianchan7786@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Lunxu Liu, M.D., Ph.D. | Department of Thoracic Surgery, West China Hospital, Sichuan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21714641 | Background | National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. | |
| 25322915 | Background |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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| Segmentectomy | Procedure | A segmentectomy removes a segment of a lung lobe anatomically, or inclusion of a portion of adjacent segment, but does not remove the whole lung lobe. Hilar and mediastinal lymph nodes should be resected or sampled. |
|
| Pulmonary function in the first year after surgery |
| From date of the 1 month\ 3 months\ 6 months\ 12 months after surgery in every recruited patient |
| 30-day Morbidity and mortality rates | From date of the recruitment, assessed up to 30 days |
| 10-year overall survival | From date of the recruitment, assessed up to 120 months |
| Zhang Y, Sun Y, Wang R, Ye T, Zhang Y, Chen H. Meta-analysis of lobectomy, segmentectomy, and wedge resection for stage I non-small cell lung cancer. J Surg Oncol. 2015 Mar;111(3):334-40. doi: 10.1002/jso.23800. Epub 2014 Oct 16. |
| 22314158 | Background | Hida Y, Teramura K, Muto J, Ohtaka K, Hase R, Nakada R, Watanabe Y, Matsui Y, Kaga K. [Indication of limited pulmonary resection for small-sized lung cancer based on preoperative clinical data]. Kyobu Geka. 2012 Jan;65(1):52-7. Japanese. |
| 24551879 | Background | Tsutani Y, Miyata Y, Nakayama H, Okumura S, Adachi S, Yoshimura M, Okada M. Appropriate sublobar resection choice for ground glass opacity-dominant clinical stage IA lung adenocarcinoma: wedge resection or segmentectomy. Chest. 2014 Jan;145(1):66-71. doi: 10.1378/chest.13-1094. |
| 25440277 | Background | Cho JH, Choi YS, Kim J, Kim HK, Zo JI, Shim YM. Long-term outcomes of wedge resection for pulmonary ground-glass opacity nodules. Ann Thorac Surg. 2015 Jan;99(1):218-22. doi: 10.1016/j.athoracsur.2014.07.068. Epub 2014 Nov 15. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |