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.

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05742945

Enrollment

240

Registered

2023-02-24

Start date

2023-02-14

Completion date

2028-08-31

Last updated

2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Lymphedema

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.

Interventions

PROCEDUREImmediate lymphatic reconstruction

Breast cancer patients receive axillary lymph node dissection and immediate lymphatic reconstruction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Female patients with unilateral breast cancer 2. Going to receive axillary lymph node dissection, or sentinel lymph node biopsy but being highly suspected of axillary metastasis preoperatively

Exclusion criteria

1. Had received axillary lymph node dissection 2. Going to receive bilateral axillary lymph node dissections 3. Already have arm lymphedema 4. Allergy to the dye used intraoperatively

Design outcomes

Primary

Measure	Time frame	Description
Arm lymphedema	Two years	Occurrence of arm lymphedema

Secondary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026