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Not yet recruiting NCT07026292

Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema

No phase Interventional Breast Cancer-Related Lymphedema Lymphedema Breast Cancer Invasive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Immediate Distal Lymphaticovenous Anastomosis (ID-LVA).
Who it may be relevant to
Registry conditions: Breast Cancer-Related Lymphedema, Lymphedema, Breast Cancer Invasive. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Procedure 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

Primary outcome measures

  • Lymphedema incidence [Time frame: From enrollment to 24 months after surgery]
Secondary outcome measures (8)
  • Lymphedema Severity [Time frame: From enrollment to 24 months after surgery]
  • Lymphedema-Associated Symptoms [Time frame: From enrollment to 24 months after surgery]
  • Quality of Life (QoL) [Time frame: From enrollment to 24 months after surgery]
  • Surgery-Related Complications [Time frame: From the day of surgery to 1 month after surgery]
  • Radiation-Related Complications [Time frame: From the day of radiation to 7 days after radiation]
  • Disease-Free Survival (DFS) [Time frame: From enrollment to 24 months after surgery]
  • Local Recurrence-Free Survival (LRFS) [Time frame: From enrollment to 24 months after surgery]
  • Overall Survival (OS) [Time frame: From enrollment to 24 months after surgery]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07026292 · E20250412 · TZ3582023-013

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗