Surgery to prevent lymphedema in breast cancer patients
Lymfo-Veneuse Anastomosen Ter Preventie Van Lymphoedeem
This study is testing whether a special surgery can help prevent lymphedema in breast cancer patients who are having their lymph nodes removed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT05601037 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of prophylactic lymphovenous anastomosis (LVA) in preventing lymphedema in patients undergoing axilla dissection for breast cancer treatment. It is a blinded randomized prospective study involving 80 patients, where one group will receive LVA during their surgery while the other group will receive standard care. Patients will be followed for two years to assess the outcomes related to lymphedema development.
Who should consider this trial
Good fit: Ideal candidates are patients with breast cancer requiring axilla dissection and who have positive lymph nodes.
Not a fit: Patients with a history of lymphedema or a BMI greater than 35 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of lymphedema in breast cancer patients post-surgery.
How similar studies have performed: While the concept of LVA is gaining traction, this specific approach is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * lymph node + breast cancer requiring dissection Exclusion Criteria: * previous lymphedema * BMI \>35
Where this trial is running
Ghent, Oost-Vlaanderen
- Uz Gent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
Study contacts
- Principal investigator: Bernard Depypere, MD — Uz Gent
- Study coordinator: Bernard Depypere, MD
- Email: bernard.depypere@ugent.be
- Phone: 093325730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.