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Clinical Trials in Egypt / NCT07614815
Starting soon Not applicable

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

NCT07614815 · tracked via the Priya Life Science Egypt tracker
Sponsor
Assiut University
Phase
Not applicable
Started
2026-05-27
Last updated
2026-05-29

Condition(s) studied

Lymphedema ArmBreast Cancer Lymphedema

Investigational drug(s) / intervention(s)

lymphatic-venous anastamosis

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

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * • 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. * Provision of written informed consent (prospective phase). Exclusion Criteria: * Bilateral upper limb lymphedema. * Active locoregional or distant oncological recurrence. * Prior lymphatic surgery on the affected limb. * Severe peripheral vascular disease. * Pregnancy or planned pregnancy during the study follow-up period. * Documented hypersensitivity to indocyanine green or iodine

Primary outcome measure(s)

  • reduction in upper limb circumference after lymphatic venous anastomosis — 6 months postoperative
    Assessment of postoperative improvement in upper limb lymphedema by comparing preoperative and postoperative limb circumference measurements following lymphaticovenous anastomosis surgery.

Trial sites (1)

FacilityCityRegionStatus
Assiut University Hospital Asyut Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07614815 on ClinicalTrials.gov ↗ ← All trials in Egypt