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Spare the vein, save the arm? surgeons test whether preserving tiny vessels cuts lymphedema risk

NCT ID NCT05246592

Knowledge-focused Sponsor: Xiangyun Zong Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Breast cancer surgery often involves removing lymph nodes from the armpit, which can lead to lasting arm swelling and reduced arm function. This study follows 258 breast cancer patients who have this node removal and compares two groups: those whose surgeons preserve small vein branches in the armpit and those whose surgeons do not. Researchers track arm swelling and arm function at 1, 6, and 12 months, and again at 5 years, to see whether preserving those vein branches makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
axillary lymph node dissection with or without preserved axillary vein branches
What this could lead to
If preserving vein branches during node removal lowers arm swelling, surgeons could adjust how they perform this operation to spare patients a common, lasting side effect.
What could go wrong
This is an observational study, so it can show a link between vein branch preservation and arm swelling but cannot prove cause and effect. Arm swelling after node removal has several causes, and results from this group of patients may not apply to everyone.

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 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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