Clinical trial · Interventional
Reduction of Arm Volume and Improvement in Lymphedema Via Surgery
Influence of the Microsugical Treatment (by Free Node Transfer And/or Lympho-venous Anastomosis (LVA)) of Secondary Lymphedema Following Axillary Lymph Node Dissection or Sentinel Node Biopsy, on the Health Related Quality of Life, Limb Volume Change, Subcutal and Dermal Thickness
- 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 clinical trial aims to evaluate the effectiveness of lymphatic microsurgical treatments in reducing limb volume in female patients with breast cancer-related lymphedema (BCRL). The study focuses on three treatments: Lymphovenous Anastomosis (LVA), Vascularized Lymph Node Transfer (VLNT), and Complex Decongestive Therapy (CDT). The main questions it aims to answer are: * Can LVA, VLNT, or their combination significantly reduce limb volume in patients with BCRL? * How does the effectiveness of these surgical interventions compare to CDT alone? Researchers will compare patients who undergo LVA, VLNT, or a combination of both to those receiving only CDT to determine the effectiveness of surgical interventions in reducing lymphedema symptoms. Participants will: * Undergo pre- and post-operative limb volume measurements. * Receive either LVA, VLNT, or combined LVA and VLNT surgery, or continue CDT alone. * Be monitored for one year to assess changes in limb volume and quality of life.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema | — | UNRESOLVED | — |
| Lymphedema Arm | — | UNRESOLVED | — |
| Lymphedema of Arm | — | UNRESOLVED | — |
| Lymphedema of Upper Limb | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer | Procedure | — | UNRESOLVED |
| Complex Decongestive Therapy | Procedure | — | UNRESOLVED |
| Lymphovenous Anastomosis | Procedure | — | UNRESOLVED |
| Vascularized Lymph Node Transfer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Lymphovenous Anastomoses (LVA)
- description
- Patients with BCRL recieve one ore more Lymphovenous Anastomoses (LVA) on the affected limb. This involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage. All patients had CDT pre- and post-op.
- interventionNames
- Procedure: Lymphovenous Anastomosis
- type
- EXPERIMENTAL
- label
- Vascularized Lymph Node Transfer (VLNT)
- description
- Patients with BCRL recieve a Vascularized Lymph Node Transfer (VLNT) on the affected limb. This involves transferring healthy lymph nodes along with their blood supply to the affected lymphoedematous area, aiding in lymphatic fluid transport and potentially promoting lymphangiogenesis. All patients had CDT pre- and post-op.
- interventionNames
- Procedure: Vascularized Lymph Node Transfer
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * at least one of the following persistent complaints of one of the upper extremities: heaviness, pain, recurrent infections Exclusion Criteria: * negative volume difference between affected and normal limb, bilateral mastectomy, bilateral axillary lymph node dissection (ALND), ongoing radio- and chemotherapy, ISL stage III, and receiving other simultaneous debulking procedures during lymphedema surgery.
References
Publications (1)
- DERIVEDZeltzer AA, Nistor A, Adriaenssens N, Deleuze J, Giunta G, Hamdi M. Outcomes of Lymphovenous Anastomoses and Vascularized Lymph Node Transplant in the Combined Surgical Treatment of Lymphedema: A Prospective Cohort Study. Plast Reconstr Surg. 2026 Jan 1;157(1):163-175. doi: 10.1097/PRS.0000000000012326. Epub 2025 Jul 22. PMID 40707214