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Postoperative upper limb edema and dysfunction generated by axillary nodes excision differs due to the ratio of axillary lymphatic and axillary vein reflux in breast cancer patients: a prospective cohort study

NCT ID NCT05246592

NEW Sponsor: Xiangyun Zong Source: ClinicalTrials.gov ↗

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Recruiting now
This trial is taking on new participants right now.
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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

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).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

258 people

The number who actually took part.

Started

Jan 2022

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients recruited in the PLEDGE study （NCT05120180）

Ages

18 to 69 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Breast Cancer Lymphedema breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer lymphedema

Contacts and locations

Locations

  • Shanghai Fengxian Central Hospital

    Shanghai, 201499, China

  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200233, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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