Clinical trial · Interventional
Lymphovenous Anastomosis for Breast Cancer Lymphedema
Lymphovenous Anastomosis for Breast Cancer-related Lymphedema: A Cohort Study
- 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 multi-center cohort study focuses on evaluating the efficacy of lymphovenous anastomosis (LVA) for treating pitting lymphedema in female breast cancer survivors. Conducted across multiple centers in Denmark, including Odense University Hospital, Herlev Hospital, Lillebaelt Hospital Vejle, and Zealand University Hospital, it aims to assess LVA's impact on reducing arm volume and improving quality of life in patients with upper extremity lymphedema secondary to breast cancer treatment. Eligible participants are adult women with unilateral arm lymphedema who show active pitting and identifiable lymphatic vessels via indocyanine green lymphography. Inclusion involves informed consent and the ability to complete Danish questionnaires. Patients are recruited from the outpatient clinics of the participating hospitals and will undergo LVA surgery under either local or general anesthesia. Following the intervention, patients are seen for data collection up to twelve months. The study measures outcomes like arm volume changes through water displacement volumetry and arm circumferential measurements, body composition via bioimpedance, health-related quality of life through LYMPH-Q, general quality of life through SF-36, arm function via DASH, and anastomosis patency via ICG lymphography. Additionally, changes in ICG lymphography images, arm fibrosis via SkinFibroMeter, and surgery duration are evaluated. The study adheres to ethical guidelines, ensuring patient safety and the integrity of the research.
Conditions
Conditions (7)
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 | — | UNRESOLVED | — |
| Lymphedema Arm | — | UNRESOLVED | — |
| Lymphedema, Breast Cancer | — | UNRESOLVED | — |
| Lymphedema of Upper Limb | — | UNRESOLVED | — |
| Lymphedema, Secondary | — | UNRESOLVED | — |
| Lymphedema; Surgical | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphovenous anastomosis (LVA) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymphovenous anastomosis (LVA)
- description
- Intervention with lymphovenous anastomosis (LVA) surgery of the affected arm.
- interventionNames
- Procedure: Lymphovenous anastomosis (LVA)
Primary outcomes (2)
- measure
- Arm volume (Water Displacement)
- timeFrame
- Baseline, six months, twelve months
- description
- Changes of arm volume difference
- measure
- Arm volume (Arm Circumferences)
- timeFrame
- Baseline, six months, twelve months
- description
- Changes of arm volume difference
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 * Female * Unilateral arm lymphedema secondary to breast-cancer treatment * Active pitting lymphedema * Presence of dermal backflow in indocyanine green lymphography * Identifiable lymphatic vessel(s) in the affected arm using an infrared camera and indocyanin green * Able to provide informed consent * Able to read, understand and complete Danish questionnaires Exclusion Criteria: * Allergy to iodine * Pregnant, breast-feeding, or aiming to conceive withing the next year * History of bilateral breast cancer
References
Publications (0)
Data not yet available