Pedicled Lateral Chest Wall Lymph-Adipofascial Flap to Prevent Arm Lymphedema After Breast Cancer Surgery

Breast cancer-related arm lymphedema is a common and long-term complication following breast cancer surgery that includes axillary lymph node dissection. Disruption of lymphatic drainage pathways in the axilla can lead to chronic arm swelling, discomfort, recurrent infections, and impaired quality of life. The risk of lymphedema is particularly high in patients with elevated body mass index and those who require regional lymph node radiation therapy.

Current preventive surgical approaches mainly focus on immediate lymphatic reconstruction using lymphatic-venous anastomosis. Although this technique may reduce early postoperative lymphedema in selected patients, its long-term effectiveness remains uncertain. In addition, the procedure requires microsurgical expertise and specialized equipment, limiting its widespread implementation. A substantial proportion of patients are also not suitable candidates due to the absence of identifiable lymphatic vessels for anastomosis.

An alternative preventive strategy is axillary reconstruction using vascularized lymph-adipofascial tissue. The lateral chest wall contains abundant adipose tissue, deep fascia, and lymphatic networks supplied by reliable perforating vessels. A pedicled lateral chest wall lymph-adipofascial flap can be harvested without microsurgical anastomosis and rotated into the axillary defect created after lymph node dissection. This approach aims to reduce postoperative dead space, modulate fibrosis, and provide a biologically favorable environment that may support lymphatic drainage and tissue remodeling.

This study is a prospective, single-arm Phase II clinical trial designed to evaluate the efficacy and safety of axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap in breast cancer patients at high risk for lymphedema. Eligible participants will undergo standard breast cancer surgery with axillary lymph node dissection, followed by immediate axillary reconstruction using the pedicled flap. The procedure adds minimal operative time and does not require microsurgical techniques.

Participants will be followed for up to 24 months after surgery. The study will assess the incidence of postoperative arm lymphedema, longitudinal changes in objective arm measurements, patient-reported quality of life, oncologic outcomes, and surgery-related complications. By focusing on a high-risk population, this study aims to clarify whether this simple and widely applicable surgical technique can safely reduce the burden of lymphedema and improve postoperative recovery after breast cancer surgery.

• Lymphedema-Free Survival of the Operated Arm at 6 and 12 Months [Срок оценки: 6 months and 12 months after surgery]
• Change in Relative Arm Volume [Срок оценки: Baseline, 6 months, 12 months, and 24 months after surgery]
• Lymphedema-Specific Quality of Life (LLIS) [Срок оценки: Baseline, 6 months, 12 months, and 24 months after surgery]
• Overall Quality of Life (EORTC QLQ-C30) [Срок оценки: Baseline, 6 months, 12 months, and 24 months after surgery]
• Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23) [Срок оценки: Baseline, 6 months, 12 months, and 24 months after surgery]
• Local Recurrence-Free Survival (LRFS) [Срок оценки: Up to 24 months after surgery]
• Regional Recurrence-Free Survival (RRFS) [Срок оценки: Up to 24 months after surgery]
• Overall Survival (OS) [Срок оценки: Up to 24 months after surgery]
• Surgery-Related Complications [Срок оценки: Up to 1 month after surgery]