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Lung cancer is the leading cause of cancer related death worldwide. Lobectomy or sub-lobectomy with mediastinal lymph node dissection is the standard surgery. About 50% lung nodules are pure ground-glass or part-solid nodules. Non-solid nodules rarely develop mediastinal lymph node metastasis. The present study is a prospective, multicenter and randomized clinical trial, comparing the overall survival and disease-free survival of whether performing mediastinal lymph node dissection in non-small cell lung cancer with ground-glass nodule CT features.
The study is a non-inferior statistical comparison, with 681 patients in each group. The anticipated enroll period is 3 years, followed by observation period of 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediastinal lymph node dissection group | Experimental | A |
|
| Spared mediastinal lymph node dissection group | Active Comparator | B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Systemic mediastinal lymph node dissection | Procedure | Systematic hilar and mediastinal lymph node dissection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival is defined as days from randomization to death from any cause, and it was censored at the last day when the patient was alive. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival | RFS time is defined as days from randomization to relapse or death for any patient. | 5 years |
| Proportion of local recurrence | Proportion of local recurrence in any kind of recurrences. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenfa Zhang, MD | Contact | +862223340123 | zhangzhenfa1973@163.com | |
| Chenguang Li, MD | Contact | +862218622819082 | cgli82@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| Zhenfa Zhenfa, MD | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ethics review board of Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37898488 | Derived | Li C, Ni Y, Liu C, Liu R, Zhang C, Song Z, Liu H, Jiang T, Zhang Z. Mediastinal lymph node dissection versus spared mediastinal lymph node dissection in stage IA non-small cell lung cancer presented as ground glass nodules: study protocol of a phase III, randomised, multicentre trial (MELDSIG) in China. BMJ Open. 2023 Oct 28;13(10):e075242. doi: 10.1136/bmjopen-2023-075242. |
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Individual participant data will be available after publication of the study.
After the follow-up period of the study.
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| Spared mediastinal lymph node dissection | Procedure | Mediastinal lymph node is spared in this group. |
|
| 5 years |
| Duration of hospitalization | Duration of hospitalization around surgery. | 1-60 days |
| Duration of chest drainage tube placement | Duration of chest drainage tube placement after surgery. | 1-60 days |
| Operation time | Time duration of surgery. | 20-180 minutes. |
| Blood loss | Blood loss during surgery. | 1-60 days |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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