Establishment and Clinical Application of Precise SLNB System in Breast Cancer: a Randomized, Multicenter, Controlled Study
NCT ID: NCT03857932
Last Updated: 2021-08-31
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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RECRUITING
NA
500 participants
INTERVENTIONAL
2016-01-01
2025-12-31
Brief Summary
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Detailed Description
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Arm1：
1. Participants received preoperative computed tomographic lymphography
2. Participants received sentinel lymph node biopsy（SLNB）
3. Participants received stained non-sentinel lymph node resection during SLNB
4. Participants received axillary reverse mapping dissection Arm2： Participants receive sentinel lymph node biopsy
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SLNB and non-slns resection
1. Participants only receive SLNB
2. preoperative CT lymphography
3. SLNB with stained non-SLN resection
4. SLNB with ARM dissection
Participants receive SLNB as well as non SLNs resection
Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection
SLNB group
Participants only receive SLNB
Participants receive SLNB as well as non SLNs resection
Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection
Interventions
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Participants receive SLNB as well as non SLNs resection
Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection
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. participants planed to perform SLNB
Exclusion Criteria
2. the result of fine needle aspiration cytology was positive
3. participants 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
Professor
Principal Investigators
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Qifeng Yang
Role: PRINCIPAL_INVESTIGATOR
Qilu Hospital, Shandong University
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
Other Identifiers
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HECT004
Identifier Type: -
Identifier Source: org_study_id
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