LymphedemaREFRESHNCT06606145
Reduction of Arm Volume and Improvement in Lymphedema Via Surgery
A study testing Lymphovenous Anastomosis, Vascularized Lymph Node Transfer and Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer in people with Lymphedema and Lymphedema Arm, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lymphedema, Lymphedema Arm, Lymphedema of Arm
- What is being tested?
- Lymphovenous Anastomosis, Vascularized Lymph Node Transfer and Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least one of the following persistent complaints of one of the upper extremities: heaviness, pain, recurrent infections
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
Read the 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.
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Arm, Lymphedema of Upper Limb, Lymphedema, Secondary
- Being tested
- Lymphovenous Anastomosis, Vascularized Lymph Node Transfer, Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer, Complex Decongestive Therapy
- Keywords
- lymphedema, lymphovenous anastomosis, vascularized lymph node transplant, LVA, VLNT
- Medical subject headings
- Lymphedema, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphovenous AnastomosisProcedure or surgery
Also called LVA, Lymphovenous Bypass, LVB, Lymphaticovenous Anastomosis
LVA involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage.
Vascularized Lymph Node TransferProcedure or surgery
Also called VLNT, Lymph Node Transfer, Lymph Node Transplant, Vascularized Lymph Node Transplant
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.
Combined Lymphovenous Anastomosis and Vascularized Lymph Node TransferProcedure or surgery
Also called LVA + VLNT, LVA & VLNT
Combined simultaneous surgical intervention during which both VLNT and LVA are performed on the operated limb.
Complex Decongestive TherapyProcedure or surgery
Also called CDT
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.
| Study group | Role | What they receive |
|---|---|---|
| Lymphovenous Anastomoses (LVA) | Experimental | 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. Receives: Procedure: Lymphovenous Anastomosis |
| Vascularized Lymph Node Transfer (VLNT) | Experimental | 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. Receives: Procedure: Vascularized Lymph Node Transfer |
| LVA + VLNT | Experimental | 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. Receives: Procedure: Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer |
| Complex Decongestive Therapy (CDT) | Active comparator | 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. Receives: Procedure: Complex Decongestive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative interlimb difference
Change in relative interlimb difference (RID) between the affected and contralateral limb
Measured: Before intervention and one year post-intervention
Secondary outcomes (1)
Number of infection episodes after surgery
The number of post-interventional erysipelas episodes is recorded for 12 months after the intervention.
Measured: One year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study startJan 2011
- Primary completionDec 2019
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moustapha Hamdi, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606145
- Sponsor's protocol ID
- BUN 143201316894
- Acronym
- REFRESH
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized individual participant data can be provided upon request by ICMJE journal editors.
Publications
Zeltzer 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.
PubMed 40707214
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06606145
- Acronym / sponsor ID
- REFRESH / BUN 143201316894
- Conditions
- Lymphedema, Lymphedema Arm, Lymphedema of Arm, Lymphedema of Upper Limb, Lymphedema, Secondary
- Keywords
- lymphedema, lymphovenous anastomosis, vascularized lymph node transplant, LVA, VLNT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 20 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lymphovenous Anastomoses (LVA) | Experimental | Procedure: Lymphovenous AnastomosisPatients 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. |
| Vascularized Lymph Node Transfer (VLNT) | Experimental | Procedure: Vascularized Lymph Node TransferPatients 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. |
| LVA + VLNT | Experimental | Procedure: Combined Lymphovenous Anastomosis and Vascularized Lymph Node TransferPatients 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. |
| Complex Decongestive Therapy (CDT) | Active comparator | Procedure: Complex Decongestive TherapyPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- at least one of the following persistent complaints of one of the upper extremities: heaviness, pain, recurrent infections
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lymphovenous AnastomosisAlso: LVA, Lymphovenous Bypass, LVB, Lymphaticovenous AnastomosisLVA involves connecting functional lymphatic vessels to nearby veins, allowing for the rerouting of lymphatic fluid into the venous system, thus improving lymphatic drainage. | Procedure or surgery | Lymphovenous Anastomoses (LVA) |
| Vascularized Lymph Node TransferAlso: VLNT, Lymph Node Transfer, Lymph Node Transplant, Vascularized Lymph Node TransplantVLNT involves transferring healthy lymph nodes along with their blood supply to the affected lymphoedematous area, aiding in lymphatic fluid transport and potentially promoting lymphangiogenesis. | Procedure or surgery | Vascularized Lymph Node Transfer (VLNT) |
| Combined Lymphovenous Anastomosis and Vascularized Lymph Node TransferAlso: LVA + VLNT, LVA & VLNTCombined simultaneous surgical intervention during which both VLNT and LVA are performed on the operated limb. | Procedure or surgery | LVA + VLNT |
| Complex Decongestive TherapyAlso: CDTThe 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 or surgery | Complex Decongestive Therapy (CDT) |
Primary outcome
Relative interlimb difference
Time frame: Before intervention and one year post-intervention
Change in relative interlimb difference (RID) between the affected and contralateral limb
1 secondary outcome
Number of infection episodes after surgery
Time frame: One year post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Derived from this study: PubMed 40707214Zeltzer 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.
- Individual participant dataSharing planned: No. Anonymized individual participant data can be provided upon request by ICMJE journal editors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lymphovenous Anastomosis, Vascularized Lymph Node Transfer and Combined Lymphovenous Anastomosis and Vascularized Lymph Node Transfer in people with Lymphedema and Lymphedema Arm, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative interlimb difference (time frame: Before intervention and one year post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.