Clinical trial NCT06606145: Reduction of Arm Volume and Improvement in Lymphedema Via Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Lymphedema Arm
Lymphedema of Arm
Lymphedema of Upper Limb
Lymphedema, Secondary
Keywords: lymphedema
lymphovenous anastomosis
vascularized lymph node transplant
LVA
VLNT
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 179
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relative interlimb difference
timeFrame: Before intervention and one year post-intervention
Secondary outcomes:
measure: Number of infection episodes after surgery
timeFrame: One year post-intervention
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel Capital
Study officials:
References: