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

NCT07415200 | Not Yet Recruiting DMC

• 1 other identifier: SYSKY-2026-001-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer-Related Lymphedema; Breast Cancer; Postoperative Complications

Keywords

Breast Cancer-Related Lymphedema; Breast Cancer; Axillary Lymph Node Dissection; Axillary Reconstruction; Preventive Surgery

Outcome Measures

Primary Outcomes (1)

• Lymphedema-Free Survival of the Operated Arm

  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.

  Up to 24 months after surgery

Secondary Outcomes (9)

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

  6 months and 12 months after surgery

• Change in Relative Arm Volume

  Baseline, 6 months, 12 months, and 24 months after surgery

• Lymphedema-Specific Quality of Life (LLIS)

  Baseline, 6 months, 12 months, and 24 months after surgery

• Overall Quality of Life (EORTC QLQ-C30)

  Baseline, 6 months, 12 months, and 24 months after surgery

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

  Baseline, 6 months, 12 months, and 24 months after surgery

Study Arms (1)

Pedicled Lymph-Adipofascial Flap Axillary Reconstruction

EXPERIMENTAL

Participants in this arm will undergo standard breast cancer surgery with axillary lymph node dissection, followed by immediate axillary reconstruction using a pedicled lateral chest wall lymph-adipofascial flap. The flap, containing adipose tissue, deep fascia, and lymphatic structures, is harvested from the lateral chest wall and rotated into the axillary defect without microsurgical anastomosis. This preventive surgical approach is intended to support lymphatic drainage and reduce the risk of postoperative arm lymphedema.

Procedure: Pedicled Lateral Chest Wall Lymph-Adipofascial Flap Axillary Reconstruction

Interventions

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.

Pedicled Lymph-Adipofascial Flap Axillary Reconstruction

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jiannan Wu, MD

CONTACT

+86 20 36997641; king8702@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)