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Sentinel lymph node biopsy(SLNB) is an established way of predicting axillary nodal metastasis in early breast cancer. We aim to determinethe,in a prospective randomized, controlled trial, effect of sentinel lymph node biopsy with para-sentinel lymph node(SLN) dissection versus sentinel lymph node biopsy without para-sentinel lymph node dissection on outcomes after breast surgery.
Aim: Compare the disease-free survival (DFS) and overall survival (OS) of breast cancer patients who are randomized to receive sentinel lymph node biopsy with para-sentinel lymph node dissection group vs. those receive only sentinel lymph node biopsy without para-sentinel lymph node dissection
Outline:
Patients are randomized assigned to the following one of two groups and are followed annually.
Arm I: Patients receive sentinel lymph node biopsy with para-sentinel lymph node dissection Arm II: Patients receive only sentinel lymph node biopsy without para-sentinel lymph node dissection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLNB with para-SLN dissection | Experimental | patients receive sentinel lymph node biopsy patients receive para-sentinel lymph node dissection |
|
| SLNB without para-SLN dissection | Experimental | patients received sentinel lymph node biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients receive SLNB | Procedure | Patients receive sentinel lymph node biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first, assessed up to 10 years. | Up to 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from randomization to death from any cause, assessed up to 10 years. | Up to 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qifeng Yang, Professor | Contact | +8618560085168 | qifengy_sdu@163.com | |
| Xiaoyan Li, Resident | Contact | +8618560080551 | wdjlc108822@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qifeng Yang | Recruiting | Jinan | Shandong | 250012 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31057616 | Derived | Ma X, Wen S, Liu B, Li D, Wang X, Kong X, Ma T, Jiang L, Yang Q. Relationship between Upper Extremity Lymphatic Drainage and Sentinel Lymph Nodes in Patients with Breast Cancer. J Oncol. 2019 Apr 1;2019:8637895. doi: 10.1155/2019/8637895. eCollection 2019. | |
| 28968971 | Derived | Li X, Chen S, Jiang L, Kong X, Ma T, Xu H, Yang Q. Precise intraoperative sentinel lymph node biopsies guided by lymphatic drainage in breast cancer. Oncotarget. 2017 Jun 27;8(38):63064-63072. doi: 10.18632/oncotarget.18624. eCollection 2017 Sep 8. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| D017437 |
| Skin and Connective Tissue Diseases |