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;