An interventional study of Lymphovenous Anastomosis and Vascularized Lymph Node Transfer in Lymphedema, Lymphedema Arm and Lymphedema of Arm, sponsored by Universitair Ziekenhuis Brussel. Completed at 1 site in Belgium. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-09-20.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment
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:
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:
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.
569 studies on the registry are indexed under Lymphedema; 136 are open to participants now.
This study's enrollment of 179 is above the median of 50 across 407 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Universitair Ziekenhuis Brussel is the lead sponsor of 374 studies on the registry; 106 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Lymphovenous Anastomosis
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.
Procedure: Vascularized Lymph Node Transfer
Patients with BCRL recieve a combined simultaneous surgical intervention during which both VLNT and one or more LVA are performed on the affected limb. All patients had CDT pre- and post-op.
Procedure: Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer
Patients with BCRL who refuse to undergo further surgical treatment after breast cancer surgery are offered conservative therapy. 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.
Procedure: Complex Decongestive Therapy
LVA involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage.
Also known as: LVA, Lymphovenous Bypass, LVB, Lymphaticovenous Anastomosis, Lymphatico-venous Anastomosis
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.
Also known as: VLNT, Lymph Node Transfer, Lymph Node Transplant, Vascularized Lymph Node Transplant
Combined simultaneous surgical intervention during which both VLNT and LVA are performed on the operated limb.
Also known as: LVA + VLNT, LVA & VLNT
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.
Also known as: CDT
Relative interlimb difference
Change in relative interlimb difference (RID) between the affected and contralateral limb
Time frame: Before intervention and one year post-intervention
Number of infection episodes after surgery
The number of post-interventional erysipelas episodes is recorded for 12 months after the intervention.
Time frame: One year post-intervention
Plan to share: No — Anonymized individual participant data can be provided upon request by ICMJE journal editors.
Ran from Jan 2011 to primary completion in Dec 2019, 107 months.
Of 208 non-industry interventional studies with no phase under Lymphedema, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 61. This study's 107 months is above that.
Counting every sponsor, half of 231 studies reached it within 23 months; a quarter within 9 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitair Ziekenhuis Brussel →