Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06067880 |
| Other study ID # |
202201453B0 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 23, 2022 |
| Est. completion date |
September 1, 2023 |
Study information
| Verified date |
September 2023 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema,
including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage.
Therefore, the use of LVA should not be limited to mild lymphedema, and its indications
should be expanded to become a primary surgical approach for more severe lymphedema cases.
Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid
recovery, minimizing the complications, and reducing medical costs.
Description:
Lymphatic-related diseases such as lymphedema often result from damage to the lymphatic
system due to tumor removal and lymph node dissection surgeries, as well as tissue fibrosis
caused by post-operative radiation therapy. This can lead to obstruction in the proximal
channels of lymphatic flow, resulting in swelling, deformity of the distal limbs, poor wound
healing, or cellulitis.
In the case of lymphatic-related diseases like lymphedema, improvement can be achieved
through surgical interventions. Surgery can be categorized into physiologic reconstruction
and volume reduction procedures. Among them, Supermicrosurgical Lymphaticovenous Anastomosis
(LVA) is a form of physiologic reconstruction. LVA involves the separation of lymphatic
vessels in the affected limb and their anastomosis with nearby small veins to alleviate limb
swelling and reduce the risk of cellulitis. When using lymphaticovenous bypass surgery to
treat lymphedema, the ideal scenario is to use veins for anastomosis that do not have venous
blood reflux. This is because veins generally have higher blood pressure than lymphatic
fluid, and if venous blood flows into the lymphatic vessels over the long term, it can reduce
the patency of the lymphaticovenous anastomosis site. The choice of anastomosis technique,
based on the size and position of the lymphatic vessels and veins, can also impact the
post-operative outcomes. Therefore, factors such as lymphatic vessel size, flow rate,
function, vein size, pressure, and the presence of reflux are closely related to the success
of lymphaticovenous bypass surgery.
Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema,
including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage.
Therefore, the use of LVA should not be limited to mild lymphedema, and its indications
should be expanded to become a primary surgical approach for more severe lymphedema cases.
Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid
recovery, minimizing the complications, and reducing medical costs.
