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Can ILR Reduce the Risk of Arm Lymphedema?

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National Taiwan University

Status

Active, not recruiting

Conditions

Breast Cancer Lymphedema

Treatments

Procedure: Immediate lymphatic reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT05742945
202207198RINB

Details and patient eligibility

About

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.

Enrollment

240 estimated patients

Sex

Female

Ages

20 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

240 participants in 2 patient groups

ILR
Experimental group
Description:
Breast cancer patients receiving axillary lymph node dissection and immediate lymphatic reconstruction
Treatment:
Procedure: Immediate lymphatic reconstruction
non-ILR
No Intervention group
Description:
Breast cancer patients receiving only axillary lymph node dissection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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