Lymphovenous Bypass for Preventing Lymphedema
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether performing a surgical procedure called lymphovenous bypass (LBP) during surgery can prevent lymphedema, a condition that causes painful swelling, instead of waiting until after the condition develops. Lymphedema often occurs after surgeries that remove lymph nodes, such as an inguinal lymphadenectomy, which is common in cancer treatments. Suitable candidates for this trial include patients undergoing inguinal lymph node removal surgery who can provide consent.
As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in preventing lymphedema.
Do I need to stop taking my current medications for the trial?
If you are taking anticoagulants (blood thinners), you will need to stop them at least 7 days before the surgery. For other medications, the trial protocol does not specify any requirements.
What prior data suggests that this procedure is safe for preventing lymphedema?
Research has shown that the lymphovenous bypass procedure (LBP) is generally safe and well-tolerated. One study found that performing this procedure during axillary lymph node dissection (a surgery to remove lymph nodes) did not lead to additional surgeries or wound issues. Another study reported no serious complications, indicating that the technique is safe for treating both primary and secondary lymphedema, a condition where excess fluid causes swelling. Overall, these findings suggest that LBP is a safe option for patients.12345
Why are researchers excited about this trial?
Researchers are excited about the lymphovenous bypass procedure (LBP) because it offers a proactive approach to preventing lymphedema rather than treating it after it develops. Most existing treatments for lymphedema, like compression garments and manual lymphatic drainage, are reactive, aiming to alleviate symptoms once they appear. LBP stands out because it connects tiny lymphatic vessels to nearby veins, potentially reducing the risk of fluid buildup before it starts. This innovative surgical method could lead to better long-term outcomes for patients undergoing inguinal lymphadenectomy.
What evidence suggests that the lymphovenous bypass procedure is effective for preventing lymphedema?
Research has shown that the lymphovenous bypass procedure (LBP), under study in this trial, can effectively treat lymphedema, particularly in breast cancer patients. Studies found that 65% of patients experienced reduced swelling, with a significant 39% reduction in limb size after six months. LBP improves the movement of lymph fluid, reducing swelling. However, it is most effective when there is no hardened tissue or fat buildup. Early initiation of LBP might lower the risk of developing lymphedema after surgery.26789
Who Is on the Research Team?
Ashleigh Francis, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo lymphovenous bypass procedure at the time of inguinal lymphadenectomy
Follow-up
Participants are monitored for safety and effectiveness after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Lymphovenous Bypass Procedure
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Lymphovenous Anastomosis Bypass Surgery - PMC
The LVB or LVA procedure is an effective and physiological operation that can have a profound impact on patients suffering from breast cancer related lymphedema ...
Lymphovenous bypass - Huang - Annals of Breast Surgery
Thirteen out of 20 patients (65%) had quantitative improvement with a mean volume differential reduction of 29% at 1 month, 36% at 3 months, 39% at 6 months, ...
A Meta-analysis of 37 Studies on the Effectiveness ...
Lymphography showed that lymphatic transport capacity was enhanced. Moreover, 12% of the patients reported that edema reappeared in the long-term, 26% required ...
The evidence for the microsurgical management of ...
LVA has been shown to be effective in restoring lymphatic drainage, but only in cases where fibrotic and adipose deposits are not seen. VLVT ...
Preventing Secondary Lymphedema: A Systematic Review ...
These findings suggest that immediate LVA is beneficial in reducing the risk of secondary lymphedema after surgical treatment of a malignancy.
National Outcomes of Prophylactic Lymphovenous Bypass ...
Prophylactic LVB at time of ALND is a generally safe and well-tolerated procedure and is not associated with increased reoperations or wound complications.
Efficacy and safety assessment of lymphovenous ...
Conclusion. LVA might be a safe technique for patients with primary and secondary lymphoedema—particularly because no serious complications were reported.
Lymphedema - Medical Clinical Policy Bulletins
Outcome data for lymph node transfer procedures are ... The authors concluded that lymphovenous bypass surgery with sleeve-in anastomosis in lymphedema ...
9.
profiles.wustl.edu
profiles.wustl.edu/en/publications/national-outcomes-of-prophylactic-lymphovenous-bypass-during-axilNational Outcomes of Prophylactic Lymphovenous Bypass ...
Prophylactic LVB at time of ALND is a generally safe and well-tolerated procedure and is not associated with increased reoperations or wound complications.
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