About this trial
This study aims to evaluate the predictive value of preoperative indocyanine green (ICG) lymphography and high-frequency ultrasound in determining the outcomes of lymphaticovenous anastomosis (LVA) in patients with post-mastectomy upper limb lymphedema. Patients undergoing LVA surgery will undergo preoperative assessment using ICG lymphography and ultrasound mapping of lymphatic vessels and recipient veins. Surgical outcomes will be assessed clinically and functionally through limb circumference measurements, symptom improvement, and postoperative imaging findings. The study seeks to identify imaging predictors associated with successful LVA outcomes and improved postoperative recovery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Female patients aged 18 to 75 years.
Unilateral secondary upper limb lymphedema following mastectomy with axillary lymph node dissection.
Minimum interval of six months from completion of oncological treatment (surgery, radiotherapy, systemic therapy) to enrollment.
ISL clinical stage I or II at the time of enrollment; late stage II eligible if patent lymphatic vessels are identified on preoperative HFUS.
Disqualifiers
Bilateral upper limb lymphedema.
Active locoregional or distant oncological recurrence.
Prior lymphatic surgery on the affected limb.
Severe peripheral vascular disease.
Trial design
Single group
Treatments tested in this trial
lymphatic-venous anastamosis
Procedure/SurgerySupermicrosurgical lymphaticovenous anastomosis performed for treatment of post-mastectomy upper limb lymphedema following preoperative imaging assessment.
Treatment groups
Trial outcomes
Primary outcomes
reduction in upper limb circumference after lymphatic venous anastomosis
Assessment of postoperative improvement in upper limb lymphedema by comparing preoperative and postoperative limb circumference measurements following lymphaticovenous anastomosis surgery.
Sponsors and contacts
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