Clinical trial NCT07026292: Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema
Official title: A Phase Ⅲ, Multicenter, Prospective, Open-Label, Controlled Study of Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema in Breast Cancer Patients Following Axillary Lymph Node Dissection and Adjuvant Radiotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer-Related Lymphedema
Lymphedema
Breast Cancer Invasive
Keywords: Supermicrosurgical Lymphaticovenous Anastomosis
Lymphedema
Breast Cancer
Prevention
Immediate Distal Lymphaticovenous Anastomosis
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2025-06-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lymphedema incidence
timeFrame: From enrollment to 24 months after surgery
Secondary outcomes:
measure: Lymphedema Severity
timeFrame: From enrollment to 24 months after surgery
measure: Lymphedema-Associated Symptoms
timeFrame: From enrollment to 24 months after surgery
measure: Quality of Life (QoL)
timeFrame: From enrollment to 24 months after surgery
measure: Surgery-Related Complications
timeFrame: From the day of surgery to 1 month after surgery
measure: Radiation-Related Complications
timeFrame: From the day of radiation to 7 days after radiation
measure: Disease-Free Survival (DFS)
timeFrame: From enrollment to 24 months after surgery
measure: Local Recurrence-Free Survival (LRFS)
timeFrame: From enrollment to 24 months after surgery
measure: Overall Survival (OS)
timeFrame: From enrollment to 24 months after surgery
Other outcomes:
Locations:
Study officials:
References: