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OpenTrials
Active, Not Recruiting

NCT Number: NCT05246592

Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Breast Cancer Lymphedema Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Branches Sparing

Procedure

The patients will undergo axillary lymph node dissection with preserved axillary vein branches

None Branches Sparing

Procedure

The patients will undergo axillary lymph node dissection without preserved axillary vein branches

Primary outcomes

  1. short-term Incidence of lymphedema

    Time frame: 1-, 6-, and 12-month

    Incidence of upper limb lymphedema on affected side at 1-, 6-, and 12-month after operation

  2. short-term Incidence of dysfunction

    Time frame: 1-, 6-, and 12-month

    Incidence of upper limb dysfunction on affected side at 1-, 6-, and 12-month after operation

Secondary outcomes

  1. long-term Incidence of lymphedema

    Time frame: 5 years

    Incidence of upper limb lymphedema on affected side 5 years after operation

  2. long-term Incidence of dysfunction

    Time frame: 5 years

    Incidence of upper limb dysfunction on affected side 5 years after operation

Other outcomes

  1. Risk model

    Time frame: 5 years

    To establish a risk model of upper limb edema and dysfunction after axillary dissection for breast cancer

Sponsors and collaborators

Lead sponsor

Xiangyun Zong

Other

Registry information

Official study title

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

Acronym: PLEDGE-R

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Feb 18, 2022
Registry last updated
Sep 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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