Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT07026292
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer Invasive
  • Breast Cancer-Related Lymphedema
  • Lymphedema

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 18, 2025
Start date
Jul 1, 2025
Status verified
May 2025
Primary completion
May 31, 2027
Completion
May 31, 2029

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: ID-LVA Group
    Immediate distal lymphaticovenous anastomosis (ID-LVA) performed concomitantly with axillary lymph node dissection (ALND)
  • No Intervention: non-ID-LVA Group
    Axillary lymph node dissection (ALND) without concurrent immediate distal lymphaticovenous anastomosis (ID-LVA)

Primary Outcome Measure

Lymphedema incidence [ Time Frame: From enrollment to 24 months after surgery ]

Central Contacts

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