Assessment of Breast Cancer-Related Arm Lymphedema

Overview

Breast cancer is a common malignant disease that threatens the health of women.As a serious chronic condition from breast cancer treatment, lymphedema, is caused by chronic accumulation of lymph fluid in the interstitial spaces of the affected limb or surrounding areas.Reported prevalence of lymphedema following treatment for breast cancer varies, ranging from 7-45% One reason for the wide variation in the reported incidence of lymphedema is the different measurement techniques used and the absence of an agreed diagnostic criteria. Nowadays, the common method include limb circumference measurement、limb volume measurement、bioimpedance spectroscopy (BIS) and self-report.Each of these methods has advantages and disadvantages . As a new method for detecting lymphedema ,some study have shown indocyanine green(ICG)lymphography can have a certain value for the detection of subclinical edema。Early detection demonstrate the greatest promise of reducing the incidence of late-stage lymphedema in breast cancer patients undergoing surgery.The aim of this study was therefore to examine the relationships between the most commonly used measures of lymphedema and the respective reliability of each of these tools. And if it's possible ,investigators are going to test which method is more sensitive for the diagnosis of clinical and subclinical lymphedema as well as the value of indocyanine green(ICG)in detecting sub-clinical lymphedema.

Full Title of Study: “Assessment of Breast Cancer-Related Arm Lymphedema—Comparison of Traditional Measurement Methods and Indocyanine Green(ICG)Lymphography”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 2022

Interventions

  • Diagnostic Test: ICG、CM、VM、BIS、self-report
    • ways to examine lymphedema

Arms, Groups and Cohorts

  • patients with lymphedema

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity of indocyanine green (ICG) lymphography
    • Time Frame: From date of enrollment until the date of first documented lymphedema, assessed up to 2 years.
    • Sensitivity means the ability of detecting patients with true edema. Specificity means the ability of detecting non-edema patients.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with breast cancer who underwent axillary, axillary and other axillary surgery.
  • Patients who have complaints about upper extremity edema and are willing to undergo examination.
  • Sign the informed consent.

Exclusion Criteria

  • Bilateral breast cancer.
  • A history of allergy to contrast agents.
  • There are arteriovenous thrombosis in the affected limb.
  • Regional lymph node recurrence
  • Did not sign informed consent.
  • Serious heart, brain and other diseases.
  • The primary lymphatic system diseases (such as lymphatic leakage).
  • Only one side of the limb received ICG angiography.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peking University People’s Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Wang Shu, Principal Investigator, Peking University People’s Hospital
  • Overall Contact(s)
    • liu siyao, +86 18801229921, dr.liusiyao@pku.edu.cn

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