Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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 anastom

Первичные конечные точки

• Lymphedema incidence [Срок оценки: From enrollment to 24 months after surgery]

Вторичные конечные точки (8)

• Lymphedema Severity [Срок оценки: From enrollment to 24 months after surgery]
• Lymphedema-Associated Symptoms [Срок оценки: From enrollment to 24 months after surgery]
• Quality of Life (QoL) [Срок оценки: From enrollment to 24 months after surgery]
• Surgery-Related Complications [Срок оценки: From the day of surgery to 1 month after surgery]
• Radiation-Related Complications [Срок оценки: From the day of radiation to 7 days after radiation]
• Disease-Free Survival (DFS) [Срок оценки: From enrollment to 24 months after surgery]
• Local Recurrence-Free Survival (LRFS) [Срок оценки: From enrollment to 24 months after surgery]
• Overall Survival (OS) [Срок оценки: From enrollment to 24 months after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07026292 · E20250412 · TZ3582023-013

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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