Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer (PLEDGE-R)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Lymphedema
• Intervention / Treatment: Procedure: Branches Sparing; Procedure: None Branches Sparing

• Study Type: Observational
• Enrollment (Estimated): 288

Contacts and Locations

• Study Contact: Name: FEN TANG, MD; Phone Number: +86(21)24058549; Email: 690476877@qq.com
• Study Contact Backup: Name: XIANGYUN ZONG, MD, PhD

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: 16 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients recruited in the PLEDGE study （NCT05120180）

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 (0-1),
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Preponderant lymphatic reflux group; high ratio of axillary lymphatic reflux to axillary vein reflux	Procedure: Branches Sparing; The patients will undergo axillary lymph node dissection with preserved axillary vein branches; Procedure: None Branches Sparing; The patients will undergo axillary lymph node dissection without preserved axillary vein branches
Preponderant venous reflux group; low ratio of axillary lymphatic reflux to axillary vein reflux	Procedure: Branches Sparing; The patients will undergo axillary lymph node dissection with preserved axillary vein branches; Procedure: None Branches Sparing; The patients will undergo axillary lymph node dissection without preserved axillary vein branches

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, MD, PhD, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Breast Cancer; Axillary Lymph Node Dissection; Post-mastectomy Lymphedema; Upper Limb Dysfunction; axillary lymphatic reflux; axillary vein reflux
• 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-20211230001

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