Can ILR Reduce the Risk of Arm Lymphedema?

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Breast Cancer Lymphedema

Intervention / Treatment
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* Procedure: Immediate lymphatic reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Had received axillary lymph node dissection Going to receive bilateral axillary lymph node dissections Already have arm lymphedema Allergy to the dye used intraoperatively

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ILR<br>Breast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction | Procedure: Immediate lymphatic reconstruction<br>* Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction<br>|
| No Intervention: non-ILR<br>Breast cancer patients receiving only axillary lymph node dissection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm lymphedema | Occurrence of arm lymphedema | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drainage amount | Drainage amount from operative wounds | Two weeks | 
| Seroma or lymphocele | Occurrence of seroma or lymphocele | One month | 
| PROM | Patient reported outcome measures by LYMPH-Q Upper Extremity Module | Two years | 
| Subclinical lymphedema | Occurrence of subclinical lymphedema | Two years |