Clinical trial · Interventional
Preoperative Indocyanine Green Lymphography and High-Frequency Ultrasound as Predictors of Lymphaticovenous Anastomosis Outcome in Post-Mastectomy Upper Limb Lymphedema
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Lymphedema | — | UNRESOLVED | — |
| Lymphedema Arm | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lymphatic-venous anastamosis | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lymphatic-venous-anastamosis
- description
- Patients with post-mastectomy upper limb lymphedema undergoing preoperative indocyanine green lymphography and high-frequency ultrasound assessment followed by lymphaticovenous anastomosis surgery.
- interventionNames
- Procedure: lymphatic-venous anastamosis
Primary outcomes (1)
- measure
- reduction in upper limb circumference after lymphatic venous anastomosis
- timeFrame
- 6 months postoperative
- description
- Assessment of postoperative improvement in upper limb lymphedema by comparing preoperative and postoperative limb circumference measurements following lymphaticovenous anastomosis surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available