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NCT Number: NCT07415200

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location contact

Jiannan Wu, MD

CONTACT

[email protected]

Jiannan Wu, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Planned to receive postoperative regional lymph node radiation therapy;
  • Ability to understand the study procedures and provide written informed consent;
  • Willingness and ability to comply with study follow-up and assessments.

Exclusion criteria

  • 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;
  • Severe hepatic or renal dysfunction, or severe cardiac insufficiency;
  • Inability to read or understand Chinese sufficiently to complete study questionnaires and assessments;
  • Pregnancy;
  • Any condition or circumstance that, in the investigator's judgment, may interfere with study compliance or follow-up.

Treatment and study plan

Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction

Procedure

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.

Primary outcomes

  1. Lymphedema-Free Survival of the Operated Arm

    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.

Secondary outcomes

  1. Lymphedema-Free Survival of the Operated Arm at 6 and 12 Months

    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.

  2. Change in Relative Arm Volume

    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.

  3. Lymphedema-Specific Quality of Life (LLIS)

    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).

  4. Overall Quality of Life (EORTC QLQ-C30)

    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).

  5. Breast Cancer-Specific Quality of Life (EORTC QLQ-BR23)

    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).

  6. Local Recurrence-Free Survival (LRFS)

    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.

  7. Regional Recurrence-Free Survival (RRFS)

    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.

  8. Overall Survival (OS)

    Time frame: Up to 24 months after surgery

    Overall survival, defined as the time from surgery to death from any cause.

  9. Surgery-Related Complications

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiannan Wu, MD

CONTACT

[email protected]

+86 20 36997641

Sponsors and collaborators

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Other

Registry information

Official study 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

Acronym: LAF-ALND

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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