Preoperative Indocyanine Green Lymphography and High-Frequency Ultrasound as Predictors of Lymphaticovenous Anastomosis Outcome in Post-Mastectomy Upper Limb Lymphedema

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAssiut University

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

Qualifiers

• 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

Treatments tested in this trial

  • lymphatic-venous anastamosis

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators