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OpenTrials
Active, Not Recruiting

NCT Number: NCT05742945

Can ILR Reduce the Risk of Arm Lymphedema?

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate Lymphatic Reconstruction

Procedure

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

Primary outcomes

  1. Arm lymphedema

    Time frame: Two years

    Occurrence of arm lymphedema

Secondary outcomes

  1. Drainage amount

    Time frame: Two weeks

    Drainage amount from operative wounds

  2. Seroma or lymphocele

    Time frame: One month

    Occurrence of seroma or lymphocele

  3. PROM

    Time frame: Two years

    Patient reported outcome measures by LYMPH-Q Upper Extremity Module

  4. Subclinical lymphedema

    Time frame: Two years

    Occurrence of subclinical lymphedema

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Feb 24, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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