Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema (SLVA-PULL)

Tianjin Medical University

Status: Not yet enrolling

Conditions: Breast Cancer-Related Lymphedema; Breast Cancer Invasive; Lymphedema

Treatments: Procedure: Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)

Study type: Interventional

Funder types: Other

Identifiers

NCT07026292

E20250412

TZ3582023-013 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

ID-LVA Group

Experimental group

Description:

Immediate distal lymphaticovenous anastomosis (ID-LVA) performed concomitantly with axillary lymph node dissection (ALND)

Treatment:

Procedure: Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)

non-ID-LVA Group

No Intervention group

Description:

Axillary lymph node dissection (ALND) without concurrent immediate distal lymphaticovenous anastomosis (ID-LVA)