Breast cancer surgery that includes removal of lymph nodes from the armpit (axillary lymph node dissection) can disrupt normal lymphatic drainage and may lead to arm swelling, known as lymphedema. This condition can cause discomfort, limit arm function, and reduce quality of life. Patients with a higher body mass index and those who receive regional lymph node radiation are at particularly high risk.
This study aims to evaluate whether a preventive surgical technique, called axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap, can reduce the risk of developing arm lymphedema after breast cancer surgery. During standard breast cancer surgery with axillary lymph node dissection, a small flap of tissue containing fat, fascia, and lymphatic tissue from the lateral chest wall is rotated into the axillary area to fill the surgical space and support lymphatic drainage.
This is a prospective, single-arm Phase II clinical study. Participants will be followed for up to 24 months after surgery to assess the occurrence of arm lymphedema, changes in arm volume and bioimpedance measurements, quality of life, and surgery-related complications. The results of this study may help determine whether this simple and widely applicable technique can safely reduce the risk of lymphedema in high-risk breast cancer patients.
Female patients aged 18 to 75 years;
Histologically confirmed invasive breast cancer;
Pathologically confirmed axillary lymph node metastasis requiring axillary lymph node dissection;
Body mass index (BMI) ≥ 25 kg/m²;
Previous surgery involving the ipsilateral axilla;
Previous radiation therapy to the ipsilateral axilla;
Evidence of distant metastatic breast cancer;
Bilateral breast cancer, or a history of contralateral breast cancer surgery;
Single group
Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction
Procedure/SurgeryThis intervention consists of immediate axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap performed at the time of standard axillary lymph node dissection for breast cancer. The flap is harvested from the lateral chest wall based on reliable perforating vessels and includes adipose tissue and deep fascia that contain native lymphatic structures. The flap is rotated into the axillary defect without microsurgical lymphatic or vascular anastomosis and is secured to surrounding tissues to fill the dead space. This technique differs from lymphatic-venous anastomosis-based procedures by avoiding microsurgical reconstruction and is designed to be easily reproducible with minimal additional operative time.
Lymphedema-Free Survival of the Operated Arm
The primary outcome is the proportion of participants who remain free of arm lymphedema after surgery. Arm lymphedema is defined by the presence of clinical symptoms or signs consistent with lymphedema together with objective measurement criteria, including a relative volume change of the operated arm or abnormal bioimpedance measurements, as assessed during follow-up.
Lymphedema-Free Survival of the Operated Arm at 6 and 12 Months
The proportion of participants who remain free of arm lymphedema at 6 and 12 months after surgery, based on clinical assessment and objective arm measurements performed during follow-up.
Change in Relative Arm Volume
Change in relative arm volume of the operated arm compared with baseline, measured using standardized objective methods and assessed at multiple postoperative time points.
Lymphedema-Specific Quality of Life (LLIS)
Change from baseline in patient-reported lymphedema-related quality of life, assessed using the Lymphedema Life Impact Scale (LLIS).
Overall Quality of Life (EORTC QLQ-C30)
Change from baseline in overall quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
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