Sentinel Lymph Node Biopsy With or Without Para-Sentinel Lymph Node Dissection in Breast Cancer
NCT ID: NCT02651142
Last Updated: 2020-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2015-01-31
2025-01-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SLNB with para-SLN dissection
patients receive sentinel lymph node biopsy patients receive para-sentinel lymph node dissection
Patients receive SLNB
Patients receive sentinel lymph node biopsy
SLNB without para-SLN dissection
patients received sentinel lymph node biopsy
Patients receive SLNB
Patients receive sentinel lymph node biopsy
Interventions
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Patients receive SLNB
Patients receive sentinel lymph node biopsy
Eligibility Criteria
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Inclusion Criteria
2. abnormal para-sentinel lymph node was found by ultrasound examination
3. ultrasound-guided fine needle aspiration cytology of these nodes were performed
4. the result of fine needle aspiration cytology was negative (no tumour cell was found)
5. patient planed to perform SLNB
Exclusion Criteria
2. the result of fine needle aspiration cytology was positive
3. patient has received neo-adjuvant system therapy
18 Years
75 Years
FEMALE
No
Sponsors
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Shandong University
OTHER
Responsible Party
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Qifeng Yang
Chairman of Department of Breast Surgery, Qilu Hospital
Locations
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Qifeng Yang
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Qifeng Yang
Role: primary
References
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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.
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.
Other Identifiers
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HECT003
Identifier Type: -
Identifier Source: org_study_id
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