Can ILR Reduce the Risk of Arm Lymphedema?
Can Immediate Lymphatic Reconstruction With Lymphatico-Venous Anastomosis Reduce the Occurrence of Arm Lymphedema in Breast Cancer Patients After Axillary Lymph Node Dissection? A Prospective Randomized Controlled Trial.
1 other identifier
interventional
240
1 country
1
Brief Summary
Breast cancer-related lymphedema (BCRL) is a debilitating, usually lifelong burden for breast cancer survivors. For the breast cancer patients receiving axillary lymph node dissection (ALND), the likelihood of BCRL is about 20%. Lymphatico-venous anastomosis (LVA) has been accepted as a method of treating extremity lymphedema. A few studies have mentioned the prophylactic effect of LVA on BCRL. However, there is still lack of a large-scale randomized controlled trial to corroborate its efficacy. Therefore, the goal of this study is to conduct a prospective randomized controlled trial to evaluate if immediate lymphatic reconstruction (ILR) with LVA could have a clinically significant effect on the reduction of BCRL occurrence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2023
CompletedFirst Submitted
Initial submission to the registry
February 15, 2023
CompletedFirst Posted
Study publicly available on registry
February 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
March 19, 2024
March 1, 2024
5.5 years
February 15, 2023
March 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Arm lymphedema
Occurrence of arm lymphedema
Two years
Secondary Outcomes (4)
Drainage amount
Two weeks
Seroma or lymphocele
One month
PROM
Two years
Subclinical lymphedema
Two years
Study Arms (2)
ILR
EXPERIMENTALBreast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction
non-ILR
NO INTERVENTIONBreast cancer patients receiving only axillary lymph node dissection
Interventions
Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction
Eligibility Criteria
You may qualify if:
- Female patients with unilateral breast cancer
- Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively
You may not qualify if:
- Had received axillary lymph node dissection
- Going to receive bilateral axillary lymph node dissections
- Already have arm lymphedema
- Allergy to the dye used intraoperatively
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hao-Chih Dai, MD, PhD
National Taiwan University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2023
First Posted
February 24, 2023
Study Start
February 14, 2023
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
March 19, 2024
Record last verified: 2024-03