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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06606145
Acronym
REFRESH
Enrollment
179
Registered
2024-09-20
Start date
2011-01-31
Completion date
2022-12-31
Last updated
2024-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema, Lymphedema Arm, Lymphedema of Arm, Lymphedema of Upper Limb, Lymphedema, Secondary

Keywords

lymphedema, lymphovenous anastomosis, vascularized lymph node transplant, LVA, VLNT

Brief summary

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.

Detailed description

This clinical trial aims to explore the effectiveness of surgical interventions for breast cancer-related lymphedema (BCRL), a chronic and often debilitating condition caused by lymphatic system damage following breast cancer treatments, such as lymph node dissection or radiation therapy. BCRL affects a significant proportion of breast cancer survivors, leading to arm swelling, discomfort, restricted mobility, and recurrent infections. Standard management of BCRL includes conservative measures known as Complex Decongestive Therapy (CDT), which involves manual lymphatic drainage, compression therapy, exercise, and skincare. While CDT offers symptomatic relief, it does not address the underlying lymphatic dysfunction. In contrast, microsurgical procedures like Lymphovenous Anastomosis (LVA) and Vascularized Lymph Node Transfer (VLNT) are emerging as more definitive treatments for BCRL, targeting the lymphatic system itself. LVA involves connecting small functional lymphatic vessels to nearby veins, allowing lymphatic fluid to bypass damaged lymph nodes and enter the venous system, improving drainage. It is particularly suited for patients with early-stage lymphedema (ISL stage I) where functional lymphatic vessels are still present. VLNT involves transferring healthy lymph nodes along with their blood supply from a donor site (such as the groin or lateral thorax) to the affected area, promoting lymphangiogenesis and improving lymphatic transport. VLNT is more suitable for advanced stages of lymphedema (ISL stage II), where lymphatic vessels are more severely damaged. The study will evaluate the outcomes of patients who undergo LVA, VLNT, or a combination of both, in comparison to a control group receiving only CDT. The surgical selection is based on preoperative imaging with indocyanine green (ICG) lymphography to assess the status of the lymphatic system. Each patient's lymphedema stage, severity, and individual characteristics are taken into consideration when choosing the most appropriate treatment. Patients will be followed for one year postoperatively to measure the effectiveness of each treatment, with the primary outcome being limb volume reduction. Limb volume will be assessed using a perometer, an objective and reliable tool for measuring arm volume. Secondary outcomes include improvement in quality of life, frequency of infections, and the need for ongoing CDT post-surgery. This study seeks to provide valuable insights into the comparative effectiveness of LVA, VLNT, and CDT in managing BCRL. While the benefits of microsurgical interventions are promising, particularly in reducing limb volume and infections, this trial aims to provide robust evidence to guide clinical decision-making and improve patient outcomes. By comparing different approaches, the study will help to clarify which surgical interventions are most beneficial for different stages of BCRL and establish clearer selection criteria for these treatments.

Interventions

LVA involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage.

VLNT involves transferring healthy lymph nodes along with their blood supply to the affected lymphoedematous area, aiding in lymphatic fluid transport and potentially promoting lymphangiogenesis.

PROCEDURECombined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer

Combined simultaneous surgical intervention during which both VLNT and LVA are performed on the operated limb.

The current standard of care for most BRCL patients includes conservative measures known as Complex Decongestive Therapy (CDT), consisting of compression therapy with low-stretch bandages, manual lymphatic drainage, exercise, and skincare.

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Relative interlimb differenceBefore intervention and one year post-interventionChange in relative interlimb difference (RID) between the affected and contralateral limb

Secondary

MeasureTime frameDescription
Number of infection episodes after surgeryOne year post-interventionThe number of post-interventional erysipelas episodes is recorded for 12 months after the intervention.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026