Does Ultrasound Guidance Axillary Incision Improve Sentinel Lymph Node Detection in Breast Cancer?
Does Using Ultrasound Guidance During Axillary Incision Improve Sentinel Lymph Node Detection Compared to Standard Methods in Breast Cancer Patients?
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Antalya, Turkey (Türkiye), 07100
- Recruiting
- Antalya Training and Research Hospital
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Contact:
- Baris R KARAKAS, Assoc. Prof.
- Phone Number: +905056706595
- Email: brkarakas@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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The ultrasound-guided axillary incision group.
In the ultrasound-guided axillary incision group, the incision is made parallel to the Langer lines under ultrasound guidance, targeting the projection of the first lymph node at the axillary entry.
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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.
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The standard hairline 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.
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In the standard group, the SLNB incision is made parallel to the Langer lines below the axillary hairline.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Intraoperative assessment of surgical performance parameters.
Time Frame: Until completion of the sentinel lymph node procedure
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Measurements will include incision details and lymph node detection times.
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Until completion of the sentinel lymph node procedure
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Collaborators and Investigators
Investigators
- Principal Investigator: Baris R KARAKAS, Assoc. Prof., Antalya Training and Research Hospital
Publications and helpful links
General Publications
- 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.
- 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 Biopsy vs No Axillary Surgery in Patients With Small Breast Cancer and Negative Results on Ultrasonography of Axillary Lymph Nodes: The SOUND Randomized Clinical Trial. JAMA Oncol. 2023 Nov 1;9(11):1557-1564. doi: 10.1001/jamaoncol.2023.3759.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AEAH-GS-BRK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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