Does Ultrasound Guidance Axillary Incision Improve Sentinel Lymph Node Detection in Breast Cancer?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAntalya Training and Research Hospital
About this trial
This single-center randomized controlled trial evaluates whether detecting the first lymph node at the axillary entrance with ultrasound guidance, followed by a targeted axillary incision over the pencil-marked projection, improves sentinel lymph node identification compared to the conventional axillary hairline landmark. The study hypothesizes that this technique enables a smaller incision, minimizes tissue dissection, and reduces operative time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
* Patients with clinical stage T1-T3 disease (tumor ≤5 cm), pN0-pN1 (one to three regional lymph nodes with micrometastases or metastases), and M0 (no distant metastasis) are eligible. Post-neoadjuvant yT1-T3, yN0-yN1, and M0 status are also eligible. All patients are undergoing axillary staging.
Clinically negative axilla
Written informed consent must be obtained prior to inclusio
Disqualifiers
Younger than 18 years
Previous breast malignancy
Pregnancy
Pre-operative diagnosis of axillary lymph node metastases
Trial population
Patients scheduled for sentinel lymph node biopsy due to breast cancer at Antalya Training and Research Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound-guided axillary incision group
Procedure/SurgeryIn the ultrasound-guided axillary incision group, the incision is made at the ultrasound-identified projection of the first lymph node at the axillary entry.
The standard axillary incision
Procedure/SurgeryIn the standard group, the SLNB incision is made parallel to the Langer lines below the axillary hairline.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: The ultrasound-guided axillary incision group.1 intervention
Group B: The standard hairline axillary incision group1 intervention
Trial outcomes
Primary outcomes
1
Intraoperative assessment of surgical performance parameters.
Measurements will include incision details and lymph node detection times.
Time frame
Until completion of the sentinel lymph node procedureSponsors and contacts
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Source ClinicalTrials.gov