Comparison Between Wedge Resection and Segmentectomy for Ground Glass Opacity- Dominant Stage IA NSCLC

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%.

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion criteria:

1. Preoperative thin-section computed tomography (TSCT) will fulfill all of the following conditions:

   * Lung cancer is suspected.
   * Lesion size is more than 5 mm but equal to or less than 20 mm.
   * Consolidation/tumor (C/T) ratio is equal to or less than 0.25.
   * The center of the tumor is located in the outer third of the lung field.
   * Preoperative TSCT estimates a surgical margin of more than1.5 cm or the tumor's diameter.
2. Preoperative clinical staging: T1a-T1bN0M0 (according to UICC2017-8thTNM staging).
3. R0 resectable in segmentectomy and wedge resections plus mediastinal lymph node resection.
4. Aged 18 to 75 years old.
5. No prior chemotherapy or thoracic radiation therapy for any malignant diseases.
6. Preoperative FEV1.0\>=1.0 L.
7. Performance status of ECOG 0 or 1.
8. Preoperative ASA scoring (American society of anesthesiology) class I -III.
9. Sufficient organ functions.
10. The patient agrees to participate in the trial and signs the informed consent form.

Exclusion criteria:

1. Quit smoking \<2 weeks.
2. Preoperative FEV1 \< 50% of the expected value.
3. Mediastinal lymph node metastasis confirmed by biopsy.
4. Pregnant or lactating women.
5. Serious mental illness.
6. With other malignant disease history within 5 years.
7. With the history of unstable angina or myocardial infarction within 6 months.
8. With the history of cerebral infarction or cerebral hemorrhage within 6 months.
9. With the history of sustained systemic corticosteroid therapy within 1 month.
10. The patient requires simultaneous surgical treatment of other diseases.
11. TSCT shows that the lesion is located in the right middle lobe.

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• BACKGROUNDTsutani 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. PMID 24551879
• BACKGROUNDCho 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. PMID 25440277