Does Ultrasound Guidance Axillary Incision Improve Sentinel Lymph Node Detection in Breast Cancer?

Official title

Does Using Ultrasound Guidance During Axillary Incision Improve Sentinel Lymph Node Detection Compared to Standard Methods in Breast Cancer Patients?

Overview

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.

Detailed description

Axillary lymph node status is a key prognostic factor in breast cancer treatment planning. Accurate axillary staging is essential for optimal management. Sentinel lymph node biopsy (SLNB) provides reliable nodal assessment and is associated with lower morbidity relative to axillary dissection. The sentinel lymph node is the initial recipient of lymphatic drainage from the primary tumor, and breast lymphatics typically drain into at least one sentinel node.

The majority of sentinel nodes are located in level I, particularly within the anterior axillary (pectoral) lymph nodes. These nodes are positioned at the inferolateral border of the pectoralis minor muscle, adjacent to the lateral thoracic vessels, and are typically in contact with the axillary tail of the breast.

The standard axillary incision for SLNB is performed parallel to the Langer line, below the axillary hairline. Blue-stained lymph nodes are identified and excised by following the blue-stained lymphatic channels.

The anterior axillary (pectoral) lymph node can be identified by placing the ultrasound transducer on the flattened lateral breast and axillary tail after appropriate patient positioning. Ultrasound guidance during an axillary incision at the projection of this lymph node allows direct access to the blue-stained sentinel lymph node. This approach reduces the extent of dissection and the need for channel tracking compared to the standard technique, resulting in a smaller incision, less tissue dissection, and shorter operative time.

This study evaluates whether ultrasound-guided projection of the first lymph node at the axillary entry during an axillary incision, followed by tracing the blue-stained lymphatic channel and identifying adjacent lymph nodes, reduces operative time and morbidity by minimizing dissection compared to the standard axillary hairline landmark approach.

Interventions

• Procedure Ultrasound-guided axillary incision group
  In the ultrasound-guided axillary incision group, the incision is made at the ultrasound-identified projection of the first lymph node at the axillary entry.
• Procedure The standard axillary incision
  In the standard group, the SLNB incision is made parallel to the Langer lines below the axillary hairline.

Primary outcome measures

• Intraoperative assessment of surgical performance parameters. [Time frame: Until completion of the sentinel lymph node procedure]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Antalya Training and Research Hospital — Antalya

Publications

• Fenech M, Burke T, Arnett G, Tanner A, Werder N. Sonographic localisation of lymph nodes suspicious of metastatic breast cancer to surgical axillary levels. J Med Radiat Sci. 2025 Mar;72(1):119-138. doi: 10.1002/jmrs.840. Epub 2024 Nov 17. PMID 39552171
• Suami H, Pan WR, Mann GB, Taylor GI. The lymphatic anatomy of the breast and its implications for sentinel lymph node biopsy: a human cadaver study. Ann Surg Oncol. 2008 Mar;15(3):863-71. doi: 10.1245/s10434-007-9709-9. Epub 2007 Nov 28. PMID 18043970
• Gentilini OD, Botteri E, Sangalli C, Galimberti V, Porpiglia M, Agresti R, Luini A, Viale G, Cassano E, Peradze N, Toesca A, Massari G, Sacchini V, Munzone E, Leonardi MC, Cattadori F, Di Micco R, Esposito E, Sgarella A, Cattaneo S, Busani M, Dessena M, Bianchi A, Cretella E, Ripoll Orts F, Mueller M, Tinterri C, Chahuan Manzur BJ, Benedetto C, Veronesi P; SOUND Trial Group. Sentinel Lymph Node Bi PMID 37733364
• Veronesi U, Paganelli G, Galimberti V, Viale G, Zurrida S, Bedoni M, Costa A, de Cicco C, Geraghty JG, Luini A, Sacchini V, Veronesi P. Sentinel-node biopsy to avoid axillary dissection in breast cancer with clinically negative lymph-nodes. Lancet. 1997 Jun 28;349(9069):1864-7. doi: 10.1016/S0140-6736(97)01004-0. PMID 9217757
• Tanis PJ, Nieweg OE, Valdes Olmos RA, Kroon BB. Anatomy and physiology of lymphatic drainage of the breast from the perspective of sentinel node biopsy. J Am Coll Surg. 2001 Mar;192(3):399-409. doi: 10.1016/s1072-7515(00)00776-6. PMID 11245383

Identifiers

NCT: NCT07338721 · AEAH-GS-BRK-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗