Lymphedema, Breast CancerLVARCTNCT05601037
LymphoVenous Anastomosis to Prevent Breast Cancer Related Lymphedema
A study testing Axilla dissection + Lymphovenous anastomosis in people with Lymphedema, Breast Cancer, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Lymphedema, Breast Cancer
- What is being tested?
- Axilla dissection + Lymphovenous anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2021to 27 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lymph node + breast cancer requiring dissection
Who cannot join
- previous lymphedema
- BMI >35
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem
Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.
Read the detailed description
The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.
- Conditions
- Lymphedema, Breast Cancer
- Being tested
- Axilla dissection + Lymphovenous anastomosis
- Medical subject headings
- Breast Cancer Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axilla dissection + Lymphovenous anastomosisProcedure or surgery
surgical bypass between lymphatic vessel and vein
| Study group | Role | What they receive |
|---|---|---|
| Axilla dissection + Lymphevenous Anastomosis | Experimental | Surgical bypass between lymphatic vessel and vein Receives: Procedure: Axilla dissection + Lymphovenous anastomosis |
| Standard surgery | No intervention | Standard surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The volume via circumferential measurements: swelling < 5%
Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5%
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start30 Jun 2021
- Primary completion27 Dec 2025 (estimated)
- Study completion27 Dec 2026 (estimated)
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 Lymphedema, Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- blinded randomized prospective
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Depypere, MD, Principal investigator, UZ GENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05601037
- Sponsor's protocol ID
- BC-09374
- Other IDs
- 2021-004751-16
- Acronym
- LVARCT
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2021
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Depypere B, Vyncke T, Dhooghe N, Claes K, Blondeel P, Van Landuyt K. A Novel Technique for Preventive Lymphovenous Anastomosis: Anastomosing a Ligated Lymphatic Vessel. Plast Reconstr Surg Glob Open. 2021 Mar 22;9(3):e3509. doi: 10.1097/GOX.0000000000003509. eCollection 2021 Mar.
PubMed 33968557
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem
- ClinicalTrials.gov ID
- NCT05601037
- Acronym / sponsor ID
- LVARCT / BC-09374
- Conditions
- Lymphedema, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 27 Dec 2025 (estimated)
- Study completion
- 27 Dec 2026 (estimated)
- First posted
- 1 Nov 2022 (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.
Lymphedema is defined as a chronic condition, caused by lymphostasis. A major part in the Western world consists of iatrogenic lymphedema caused by surgery to the lymph nodes of the axilla or groin. Prophylactic lymphovenous anastomosis (LVA) could be beneficial in the prevention of lymphedema of the extremities.
Detailed description
The investigator is performing a blinded randomized prospective study on 80 patients undergoing an axilla dissection for their breast cancer treatment. One group will receive a LVA at the time of their axilla dissection. Other group will receive standard of care. Follow-up is 2 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- blinded randomized prospective
| Arm | Type | Receives |
|---|---|---|
| Axilla dissection + Lymphevenous Anastomosis | Experimental | Procedure: Axilla dissection + Lymphovenous anastomosisSurgical bypass between lymphatic vessel and vein |
| Standard surgery | No intervention | –Standard surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- lymph node + breast cancer requiring dissection
Key exclusion criteria (2 listed)
- previous lymphedema
- BMI >35
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 |
|---|---|---|
| Axilla dissection + Lymphovenous anastomosissurgical bypass between lymphatic vessel and vein | Procedure or surgery | Axilla dissection + Lymphevenous Anastomosis |
Primary outcome
The volume via circumferential measurements: swelling < 5%
Time frame: 2 years
Comparing the volume of the arm at each study visit via circumferential measurements: swelling < 5%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 33968557Depypere B, Vyncke T, Dhooghe N, Claes K, Blondeel P, Van Landuyt K. A Novel Technique for Preventive Lymphovenous Anastomosis: Anastomosing a Ligated Lymphatic Vessel. Plast Reconstr Surg Glob Open. 2021 Mar 22;9(3):e3509. doi: 10.1097/GOX.0000000000003509. eCollection 2021 Mar.
- Individual participant dataSharing planned: No
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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.
Bernard Depypere, MD principal investigator
UZ GENT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axilla dissection + Lymphovenous anastomosis in people with Lymphedema, Breast Cancer, run by University Hospital, Ghent 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 2 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: looking for participants now, as of the sponsor's last update on 8 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernard Depypere, MD (093325730, bernard.depypere@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The volume via circumferential measurements: swelling < 5% (time frame: 2 years). 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 NCT05601037, 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 8 Nov 2024.