Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

N/ANot Yet RecruitingNCT07026292

Tianjin Medical University Cancer Institute and Hospital120 enrolled

Overview

Breast cancer-related lymphedema (BCRL) is one of the most common chronic complications following breast cancer treatment. This study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. Based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (ID-LVA) following axillary lymph node dissection (experimental group) or not (control group). The study aims to evaluate the safety and efficacy of ID-LVA in preventing breast cancer-related upper limb lymphedema.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Breast Cancer-Related Lymphedema Lymphedema Breast Cancer Invasive

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>=18 years; 2. Female; 3. Pathologically confirmed invasive breast cancer; 4. Unilateral breast cancer; 5. Clinical stage T1-4 and N1-3 (post-neoadjuvant therapy staging for patients receiving neoadjuvant treatment); 6. No clinical or radiographic evidence of distant metastasis; 7. Scheduled to undergo axillary lymph node dissection with planned adjuvant radiotherapy; 8. Willing and able to provide written informed consent. Exclusion Criteria: 1. Currently participating in other clinical trials that, in the investigator's judgment, may affect upper limb lymphatic drainage. 2. No definitive indication for axillary lymph node dissection or adjuvant radiotherapy after neoadjuvant therapy. 3. Pregnant or lactating women. 4. Patients undergoing concurrent autologous tissue flap breast reconstruction or chest wall repair. 5. Upper limb deformities, prior upper limb trauma, or surgical history that, in the investigator's assessment, may compromise lymphatic drainage. 6. Pre-existing upper limb lymphedema at baseline.

Outcomes

Primary Outcomes

Lymphedema incidence

Breast cancer-related lymphedema (BCRL) was assessed using relative volume change (RVC) derived from circumferential measurements of both upper limbs. Certified lymphedema therapists performed standardized measurements at anatomical landmarks: the web space, ulnar styloid midpoint, and points 10, 20, 30, and 40 cm above the ulnar styloid; axillary measurements were added if needed. Segmental volumes were calculated using the truncated cone formula: V = (πh/12) × (C₁² + C₁C₂ + C₂²), where h = 10 cm, and C₁, C₂ are circumferences at segment ends. Total arm volume was the sum of all segments. RVC was computed as: RVC = (A₂U₁) / (A₁U₂) × 100%, where A₁/A₂ = pre-/postoperative volume of the affected arm, and U₁/U₂ = pre-/postoperative volume of the unaffected arm. If weight fluctuated significantly, weight-adjusted change (WAC) was calculated: WAC = (A₂ × W₁) / (W₂ × A₁) - 1, where W₁ and W₂ represent the preoperative and postoperative body weight.