Lymphedema ArmNCT07614815
Preoperative Indocyanine Green Lymphography and High-Frequency Ultrasound as Predictors of Lymphaticovenous Anastomosis Outcome in Post-Mastectomy Upper Limb Lymphedema
A study testing lymphatic-venous anastamosis in people with Lymphedema Arm and Breast Cancer Lymphedema, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphedema Arm, Breast Cancer Lymphedema
- What is being tested?
- lymphatic-venous anastamosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 27 May 2026to 1 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Lymphedema Arm, Breast Cancer Lymphedema
- Being tested
- lymphatic-venous anastamosis
- Keywords
- lymph-venous-anastamosis, ICG, HFUS
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphatic-venous anastamosisProcedure or surgery
Supermicrosurgical lymphaticovenous anastomosis performed for treatment of post-mastectomy upper limb lymphedema following preoperative imaging assessment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: lymphatic-venous anastamosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start27 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema ArmStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Hisham Zayan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614815
- Sponsor's protocol ID
- ASSIUT-LVA-2026-01
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided