Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

NCT ID: NCT07026292

Last Updated: 2025-06-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2029-05-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ID-LVA Group

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

Group Type: EXPERIMENTAL

Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)

Intervention Type: 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.

non-ID-LVA Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Immediate Distal Lymphaticovenous Anastomosis (ID-LVA)

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.

Intervention Type: PROCEDURE

Other Intervention Names

Supermicrosurgical Lymphaticovenous Anastomosis

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hongmeng Zhao

Role: CONTACT

zhaohongmeng@tjmuch.com

+86 22 6515 0123 ext. 8500/8520

Other Identifiers

TZ3582023-013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E20250412

Identifier Type: -

Identifier Source: org_study_id