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Active, Not Recruiting

NCT Number: NCT05120180

Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer

The purpose of this study is to compare the effects of axillary lymph node dissection with or without axillary vein branches reservation on the affected upper limb edema and dysfunction in breast cancer patients, and to explore the solutions to prevent the affected upper limb edema and dysfunction after ALND.

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

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 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 (0-2),
  • 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

axillary lymph node dissection with vein branches reservation

Procedure

Spare the vein branches when ALND being performed

axillary lymph node dissection without vein branches reservation

Procedure

Don't spare the vein branches when ALND being performed

Primary outcomes

  1. short-term Incidence of lymphedema

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

    short-term Incidence of upper limb lymphedema on affected side after operation

  2. short-term Incidence of dysfunction

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

    short-term Incidence of upper limb dysfunction on affected side after operation

Secondary outcomes

  1. long-term Incidence of lymphedema

    Time frame: 5 yearsye

    long-term Incidence of upper limb lymphedema on affected side after operation

  2. long-term Incidence of dysfunction

    Time frame: 5 years

    long-term Incidence of upper limb dysfunction on affected side after operation

Other outcomes

  1. TFS

    Time frame: 5 years

    tumor-free survival

Sponsors and collaborators

Lead sponsor

Xiangyun Zong

Other

Registry information

Official study title

Postoperative Upper Limb Edema and Dysfunction Generated by Axillary Nodes Excision With or Without Axillary Vein Branches Reservation in Breast Cancer Patients: a Prospective, Multiple-center, Double-blinded, Randomized Controlled Study

Acronym: PLEDGE-Surgery

Important dates

Study start
2022
Primary completion
2024
Study completion
2029
First posted
Nov 15, 2021
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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