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Pedicled Lateral Chest Wall Lymph-Adipofascial Flap to Prevent Arm Lymphedema After Breast Cancer Surgery
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-02-20
Completion Date
2030-03-01
Last Updated
2026-02-17
Healthy Volunteers
No
Interventions
Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction
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.
Locations (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China