Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

NCT07026292 | Not Yet Recruiting DMC

• 2 other identifiers: E20250412TZ3582023-013
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer-Related Lymphedema; Lymphedema; Breast Cancer Invasive

Keywords

Supermicrosurgical Lymphaticovenous Anastomosis; Lymphedema; Breast Cancer; Prevention; Immediate Distal Lymphaticovenous Anastomosis

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 24 months after surgery

Secondary Outcomes (8)

• Lymphedema Severity

  From enrollment to 24 months after surgery

• Lymphedema-Associated Symptoms

  From enrollment to 24 months after surgery

• Quality of Life (QoL)

  From enrollment to 24 months after surgery

• Surgery-Related Complications

  From the day of surgery to 1 month after surgery

• Radiation-Related Complications

  From the day of radiation to 7 days after radiation

Study Arms (2)

ID-LVA Group

EXPERIMENTAL

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

Procedure: Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)

non-ID-LVA Group

NO INTERVENTION

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

Interventions

Immediate Distal Lymphaticovenous Anastomosis (ID-LVA) PROCEDURE

ID-LVA (Immediate Distal Lymphaticovenous Anastomosis) is an supermicrosurgical technique performed during axillary lymph node dissection (ALND) to prevent breast cancer-related lymphedema, offering the dual advantages of immediate intervention and radiation-field avoidance. Compared to LYMPHA (Lymphatic Microsurgical Preventive Healing Approach), which utilizes proximal axillary anastomoses within the radiation field with larger vessels and higher venous pressure, ID-LVA creates precise anastomoses between 0.3-0.8mm distal superficial lymphatic vessels and low-pressure venules in the upper arm. In contrast to DD-LVA (Delayed Distal Lymphaticovenous Anastomosis) performed postoperatively (typically 4-12 weeks after ALND) for subclinical lymphedema, ID-LVA provides earlier prevention by utilizing undamaged lymphatics and avoids the need for a second procedure.

Also known as: Supermicrosurgical Lymphaticovenous Anastomosis

ID-LVA Group

Eligibility Criteria

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

You may qualify if:

• Age \>=18 years;
• Female;
• Pathologically confirmed invasive breast cancer;
• Unilateral breast cancer;
• Clinical stage T1-4 and N1-3 (post-neoadjuvant therapy staging for patients receiving neoadjuvant treatment);
• No clinical or radiographic evidence of distant metastasis;
• Scheduled to undergo axillary lymph node dissection with planned adjuvant radiotherapy;
• Willing and able to provide written informed consent.

You may not qualify if:

• Currently participating in other clinical trials that, in the investigator's judgment, may affect upper limb lymphatic drainage.
• No definitive indication for axillary lymph node dissection or adjuvant radiotherapy after neoadjuvant therapy.
• Pregnant or lactating women.
• Patients undergoing concurrent autologous tissue flap breast reconstruction or chest wall repair.
• Upper limb deformities, prior upper limb trauma, or surgical history that, in the investigator's assessment, may compromise lymphatic drainage.
• Pre-existing upper limb lymphedema at baseline.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Breast Cancer Lymphedema; Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hongmeng Zhao

CONTACT

+86 22 6515 0123; zhaohongmeng@tjmuch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 18, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2029
• Last Updated: June 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From June 1, 2025 to May 31, 2029.