Trials. 2026 Feb 26. doi: 10.1186/s13063-026-09518-5. Online ahead of print.
ABSTRACT
BACKGROUND AND AIMS: Cancer-related lymphedema (CRLE), a chronic complication of cancer treatment, affects 39-73% of patients post-lymph node dissection, impacting physical health, social participation, and finances. Prophylactic immediate lymphatic reconstruction (ILR) via lymphaticovenous anastomosis (LVA) has shown potential in reducing CRLE incidence by two-thirds following axillary and inguinal node dissection. However, rigorous phase III studies with long-term follow-up are still needed to confirm these promising results. This study aims to evaluate the efficacy, safety, and long-term outcomes of ILR in preventing CRLE in a prospective, controlled trial setting.
METHODS/DESIGNS: A phase III randomized controlled trial will evaluate an intervention in adult patients undergoing axillary or groin node dissection for cutaneous malignancy. Block randomization will stratify participants by upper or lower extremities. Primary outcomes include lymphedema incidence and quality-of-life measures. Statistical analyses will compare lymphedema rates and quality-of-life outcomes between intervention and control groups.
OBJECTIVES: The primary endpoint is to assess the impact of prophylactic LVA on the presence or absence of lymphedema post axillary or groin lymphadenectomy and participant quality of life. The secondary endpoint is the incidence of complications related to nodal dissection.
SIGNIFICANCE: CRLE, a common complication of cancer surgery and radiotherapy, severely impacts patients’ lives and healthcare resources. Reducing its incidence by two-thirds would significantly improve outcomes for cancer survivors and decrease treatment demands. This underscores the need for advanced research in prevention and early intervention strategies to mitigate lymphedema’s burden on patients and healthcare systems.
TRIAL REGISTRATION: ClinicalTrials.gov ID NCT05136079 2021-11-02.
PMID:41749241 | DOI:10.1186/s13063-026-09518-5
