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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Lymphedema
• Intervention / Treatment: Procedure: axillary lymph node dissection with vein branches reservation; Procedure: axillary lymph node dissection without vein branches reservation

• Study Type: Interventional
• Enrollment (Estimated): 261
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: FEN TANG, M.D., Ph.D.P; Phone Number: +86(21)24058549; Email: 690476877@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Recruiting
      • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
      • Contact: FEN TANG, MD; Phone Number: +86(21)24058549; Email: 690476877@qq.com
      • Principal Investigator: XIANGYUN ZONG, MD, PHD
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: YANG YU, M.D.; Phone Number: +86（21）88122222; Email: yuyangkaiyu@163.com
      • Principal Investigator: HONGJIAN YANG, M.D.
      • Sub-Investigator: YANG YU, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Branches Sparing; The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches	Procedure: axillary lymph node dissection with vein branches reservation; Spare the vein branches when ALND being performed
Active Comparator: None Branches Sparing; The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches	Procedure: axillary lymph node dissection without vein branches reservation; Don't spare the vein branches when ALND being performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of lymphedema	Incidence of upper limb lymphedema on affected side after operation	1 year
Incidence of dysfunction	Incidence of upper limb dysfunction on affected side after operation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of lymphedema	Incidence of upper limb lymphedema on affected side after operation	1 month, 6 month
Incidence of dysfunction	Incidence of upper limb dysfunction on affected side after operation	1 month, 6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of lymphedema and dysfunction	Incidence of upper limb lymphedema and dysfunction on affected side after operation	5 year

Collaborators and Investigators

• Sponsor: Xiangyun Zong
• Investigators: Study Chair: XIANGYUN ZONG, M.D., Ph.D.P, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 2, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Axillary Lymph Node Dissection; Post-mastectomy Lymphedema; Upper Limb Dysfunction; Axillary Vein Branches Reservation
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Postoperative Complications; Breast Diseases; Breast Neoplasms; Lymphedema; Breast Cancer Lymphedema
• Other Study ID Numbers: JTU-6H-20211011001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No