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

NCT07614815 | Not Yet Recruiting DMC

• 1 other identifier: ASSIUT-LVA-2026-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema Arm; Breast Cancer Lymphedema

Keywords

lymph-venous-anastamosis; ICG; HFUS

Outcome Measures

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.

  6 months postoperative

Study Arms (1)

lymphatic-venous-anastamosis

EXPERIMENTAL

Patients with post-mastectomy upper limb lymphedema undergoing preoperative indocyanine green lymphography and high-frequency ultrasound assessment followed by lymphaticovenous anastomosis surgery.

Procedure: lymphatic-venous anastamosis

Interventions

lymphatic-venous anastamosis PROCEDURE

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

lymphatic-venous-anastamosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

mohammed hisham abdelhafez, MD

CONTACT

+201153353229; mohammedzayan@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist university

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

EG (1)