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Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer (PLEDGE-R)

X

Xiangyun Zong

Status

Active, not recruiting

Conditions

Breast Cancer Lymphedema

Treatments

Procedure: None Branches Sparing
Procedure: Branches Sparing

Study type

Observational

Funder types

Other

Identifiers

NCT05246592
JTU-6H-20211230001

Details and patient eligibility

About

The purpose of this study is to compare the difference in the incidence of upper limb edema and dysfunction between the Preponderant lymphatic reflux group (high ratio of axillary lymphatic reflux to axillary vein reflux) and the Preponderant venous reflux group (low ratio of axillary lymphatic reflux to axillary vein reflux).

Enrollment

258 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18-69 years old,
  • Regardless of gender,
  • Breast masses were diagnosed by histology and pathology, stage II -III.
  • Clinical palpation of axillary lymph nodes is positive, or
  • Axillary lymph node puncture pathology is positive, or
  • The multidisciplinary treatment cooperation group (MDT) recommends axillary lymph node dissection,
  • Good physical state score (0-1),
  • No severe organ complications,
  • No congenital or acquired diseases affecting the normal morphology and functional activities of the upper limbs,
  • Informed consent, understanding and compliance with research requirements.

Exclusion criteria

  • Pregnancy or lactation,
  • Inflammatory breast cancer,
  • Clinical findings of metastatic lesions,
  • Sentinel lymph node biopsy was negative,
  • History of upper limb or shoulder, chest, back trauma or surgery,
  • Previous history of local radiotherapy,
  • History of other tumors,
  • Vascular embolic disease,
  • Those who are unable to comply with the clinical trial requirements for any reason.

Trial design

258 participants in 2 patient groups

Preponderant lymphatic reflux group
Description:
high ratio of axillary lymphatic reflux to axillary vein reflux
Treatment:
Procedure: None Branches Sparing
Procedure: Branches Sparing
Preponderant venous reflux group
Description:
low ratio of axillary lymphatic reflux to axillary vein reflux
Treatment:
Procedure: None Branches Sparing
Procedure: Branches Sparing

Trial contacts and locations

3

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Central trial contact

XIANGYUN ZONG, MD, PhD; FEN TANG, MD

Data sourced from clinicaltrials.gov

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