Skip to content

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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07614815
Enrollment
30
Registered
2026-05-29
Start date
2026-05-27
Completion date
2028-06-01
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Lymphedema, Lymphedema Arm

Keywords

lymph-venous-anastamosis, ICG, HFUS

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.

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.

Interventions

PROCEDURElymphatic-venous anastamosis

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 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

Design outcomes

Primary

MeasureTime frameDescription
reduction in upper limb circumference after lymphatic venous anastomosis6 months postoperativeAssessment of postoperative improvement in upper limb lymphedema by comparing preoperative and postoperative limb circumference measurements following lymphaticovenous anastomosis surgery.

Countries

Egypt

Contacts

CONTACTmohammed hisham abdelhafez, MD
mohammedzayan@aun.edu.eg+201153353229

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026