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临床试验/NCT07338721
NCT07338721已完成不适用

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

Antalya Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Intraoperative assessment of surgical performance parameters.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • * 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

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Ultrasound-guided axillary incision group (Procedure)

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.

干预措施: The standard axillary incision (Procedure)

结局指标

主要结局

Intraoperative assessment of surgical performance parameters.

时间窗: Until completion of the sentinel lymph node procedure

Measurements will include incision details and lymph node detection times.

次要结局

未报告次要终点

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Baris Karakas

Assoc. Prof.

Antalya Training and Research Hospital

研究点 (2)

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