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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • lymphatic-venous anastamosis

    Procedure/Surgery

    Supermicrosurgical lymphaticovenous anastomosis performed for treatment of post-mastectomy upper limb lymphedema following preoperative imaging assessment.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: lymphatic-venous-anastamosisExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months postoperative

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: