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NCT Number: NCT07614815

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University Hospital

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lymphatic-venous anastamosis

Procedure

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

Primary outcomes

  1. reduction in upper limb circumference after lymphatic venous anastomosis

    Time frame: 6 months postoperative

    Assessment of postoperative improvement in upper limb lymphedema by comparing preoperative and postoperative limb circumference measurements following lymphaticovenous anastomosis surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

mohammed hisham abdelhafez, MD

CONTACT

[email protected]

+201153353229

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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