Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606145
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Reduction of Arm Volume and Improvement in Lymphedema Via Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Influence of the Microsugical Treatment by Free Node Transfer Andor 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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REFRESH
Brief 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
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None