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Clinical study for the effectiveness of disposable biopsy needle in the diagnosis of Lymph node metastasis in early breast cancer

Clinical study for the effectiveness of disposable biopsy needle in the diagnosis of Lymph node metastasis in early breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025422
Enrollment
Unknown
Registered
2019-08-26
Start date
2019-08-21
Completion date
Unknown
Last updated
2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymph node metastasis in breast cancer

Interventions

1:Vertical method
2:Rotation method
3: Mixed method
A:Short diameter is less than 5mm
B:Short diameter between 5mm to 10mm
C:Short diameter more than 10mm

Sponsors

the Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with a history of breast cancer: including patients who newly diagnosed breast cancer, patients who have undergone breast cancer surgery or chemotherapyneoadjuvant therapy; 2. Patients who agree to participate in this clinical study and sign an informed consent form; 3. Male and female aged 18-75 years old; 4. Patients who have undergone for axillary lymph node dissection, but lymph nodes appear again in the armpit; 5. Patients with abnormal axillary lymph nodes that need to be diagnosed or differentially diagnosed,the ultrasond diagnostic criteria for abnormal lymph nodes are as follows: (1) Lymph node transverse diameter > 10mm (neck lymph node transverse diameter > 7mm) or aspect ratio < 2; (2) The edge of the lymph nodes is irregular; (3) Lymphatic structure disappear; (4) lymph node cortical thickness is greater than 1/2 of the lymph node diameter; (5) The echoes in the lymph nodes are uneven, and there is a focal echo-free zone or a strong echo in the spot; (6) Edematous adjacent soft tissue, lymph nodes merge with each other; (7) Lymph nodes compress peripheral tissues or blood vessels; 6. Agree to surgically remove abnormal lymph nodes.

Exclusion criteria

Exclusion criteria: (1) Those who are allergic to local anesthetics(such as lidocaine ) or who used to have severe drug allergic reactions; (2) Those who cannot tolerate ultrasound interventional surgery; (3) Those who have history of severe cardiovascular disease (such as treatment-requiring arrhythmia or anginacoronary stentingangioplastycoronary artery bypass grafting); cardiac insufficiency (EF<60%); (4) Those who have previous history or complications of arterial thrombosis (such as cerebral thrombosis, transient ischemic attack or myocardial infarction)venous thrombosis (such as deep vein thrombosis, pulmonary embolism); (5) Anticoagulant or antiplatelet drugs are being used 2 weeks before surgery(such as aspirin, warfarin, clopidogrel, heparin, rivaroxaban (Saban), dipyridamole, cilostazoletc.fibrinolytic drugs such as urokinase); (6) Those who have previous history of coagulation abnormalities or abnormal blood coagulation, such as prothrombin time- international normalized ratio (PT-INR), activated partial thromboplastin time (APTT) values outside the normal range of 20%An abnormal increase of D-Dimer (7) Patients who have bleeding disorders (such as immune thrombocytopenia ITPplatelets <50 * 10^9/L); (8) Patients who are not suitable for the trial; (9) Those who have participated in other clinical research within 3 months before the election; (10) Those who are obviously infected with the puncture site; (11) Those who refuse surgery.

Design outcomes

Primary

MeasureTime frame
Comparison of fine needle puncture and surgical pathology;Positive rate of different lymph node size;Effectiveness of different puncture methods;

Countries

China

Contacts

Public ContactLiang Weixiang

the Third Affiliated Hospital of Guangzhou Medical University

Weixiangl@163.com+86 13503089717

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026