Using ultrasound to guide a smaller axillary incision for sentinel lymph node biopsy
Does Using Ultrasound Guidance During Axillary Incision Improve Sentinel Lymph Node Detection Compared to Standard Methods in Breast Cancer Patients?
This will see if marking the first axillary lymph node with ultrasound helps surgeons find and remove the sentinel lymph node more easily in people having axillary staging for breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Antalya Training and Research Hospital Government |
| Locations | 1 site (Antalya) |
| Trial ID | NCT07338721 on ClinicalTrials.gov |
What this trial studies
This single-center randomized controlled trial compares an ultrasound-guided axillary incision placed directly over the first detected lymph node projection to the conventional incision placed under the axillary hairline. Patients eligible for sentinel lymph node biopsy are randomized to either the ultrasound-marked targeted incision or the standard landmark-based incision. Surgeons will follow blue-stained lymphatic channels and record sentinel lymph node identification rates, incision size, extent of tissue dissection, and operative time. The hypothesis is that ultrasound guidance permits a smaller incision, less dissection, and faster, more reliable sentinel node access.
Who should consider this trial
Good fit: Adults with clinical T1-T3 breast tumors (≤5 cm), clinically node-negative or appropriate post-neoadjuvant status (yT1-T3, yN0-yN1), M0, and scheduled for axillary staging who can give written informed consent are ideal candidates.
Not a fit: People with preoperative diagnosis of axillary node metastases, multiple clinically suspicious nodes, prior breast malignancy, pregnancy, or those under 18 are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could allow smaller incisions, less tissue dissection, shorter operations, and more reliable sentinel lymph node identification for patients undergoing axillary staging.
How similar studies have performed: Ultrasound-based localization of axillary nodes has been used successfully in other targeted node procedures, but using ultrasound specifically to place a smaller axillary incision for sentinel node biopsy is a relatively novel approach with limited randomized data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \* 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 Exclusion Criteria: * Younger than 18 years * Previous breast malignancy * Pregnancy * Pre-operative diagnosis of axillary lymph node metastases * The presence of multiple clinically involved or suspicious lymph nodes * Unable or unwilling to provide informed consent.
Where this trial is running
Antalya
- Antalya Training and Research Hospital — Antalya, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Baris R KARAKAS, Assoc. Prof. — Antalya Training and Research Hospital
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.