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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Lymphedema; Lymphedema Arm
• Intervention / Treatment: Procedure: lymphatic-venous anastamosis

Detailed Description

Post-mastectomy upper limb lymphedema is a chronic and progressive condition that significantly affects quality of life and upper limb function. Lymphaticovenous anastomosis (LVA) has emerged as an effective physiologic surgical treatment for selected patients with functioning lymphatic channels. However, predicting surgical success remains challenging.

Indocyanine green (ICG) lymphography and high-frequency ultrasound are increasingly used for preoperative evaluation and surgical planning in lymphedema surgery. These imaging modalities allow visualization of lymphatic vessel patency, lymphatic flow patterns, vessel diameter, and recipient vein characteristics, potentially improving patient selection and operative outcomes.

This prospective interventional study aims to assess the role of preoperative ICG lymphography and high-frequency ultrasound as predictors of successful LVA outcomes in patients with post-mastectomy upper limb lymphedema.

Eligible patients diagnosed with secondary upper limb lymphedema following breast cancer treatment will undergo detailed clinical evaluation, limb measurements, ICG lymphography staging, and ultrasound vessel mapping before surgery. Patients will then undergo supermicrosurgical lymphaticovenous anastomosis.

Primary outcomes will include postoperative reduction in limb circumference and improvement in clinical symptoms. Secondary outcomes will include correlation between imaging findings and surgical success, postoperative complication rates, and patient-reported functional improvement.

The study is expected to contribute to improving patient selection criteria and optimizing preoperative planning for LVA surgery in breast cancer-related lymphedema.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohammed hisham abdelhafez, MD; Phone Number: +201153353229; Email: mohammedzayan@aun.edu.eg

Study Locations

• Egypt
  • Asyut, Egypt, 71515
    • Assiut University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lymphatic-venous-anastamosis; 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; Supermicrosurgical lymphaticovenous anastomosis performed for treatment of post-mastectomy upper limb lymphedema following preoperative imaging assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): May 27, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: ICG; HFUS; lymph-venous-anastamosis
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Lymphatic Diseases; Lymphedema; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Breast Cancer Lymphedema
• Other Study ID Numbers: ASSIUT-LVA-2026-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No