Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
NCT Number: NCT07415200
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.
Trial opening soon.
Get Notified18 year–75 year
Female
Interventional
Not applicable
Guangzhou, Guangdong, 510000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This 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.
Time frame: Up to 24 months after surgery
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.
Time frame: 6 months and 12 months after surgery
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.
Time frame: Baseline, 6 months, 12 months, and 24 months after surgery
Change in relative arm volume of the operated arm compared with baseline, measured using standardized objective methods and assessed at multiple postoperative time points.
Time frame: Baseline, 6 months, 12 months, and 24 months after surgery
Change from baseline in patient-reported lymphedema-related quality of life, assessed using the Lymphedema Life Impact Scale (LLIS).
Time frame: Baseline, 6 months, 12 months, and 24 months after surgery
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).
Time frame: Baseline, 6 months, 12 months, and 24 months after surgery
Change from baseline in breast cancer-specific quality of life, assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module (EORTC QLQ-BR23).
Time frame: Up to 24 months after surgery
Local recurrence-free survival is defined as the time from the date of surgery to the first documented local recurrence in the ipsilateral axilla, as confirmed by imaging studies or pathological examination.
Time frame: Up to 24 months after surgery
Regional recurrence-free survival is defined as the time from the date of surgery to the first documented recurrence in regional lymph node areas, including the supraclavicular, or internal mammary lymph nodes, confirmed by imaging studies or pathological examination.
Time frame: Up to 24 months after surgery
Overall survival, defined as the time from surgery to death from any cause.
Time frame: Up to 1 month after surgery
Incidence of surgery-related complications, including but not limited to postoperative bleeding, flap-related complications (such as fat necrosis or flap necrosis), wound infection, and postoperative seroma, assessed during the postoperative period.
Contact information is provided by the study sponsor or research team.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Other
Efficacy and Safety of Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction for the Prevention of Breast Cancer-Related Arm Lymphedema: A Prospective, Single-Arm, Phase II Clinical Study
Acronym: LAF-ALND
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