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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05246592

Acronym

PLEDGE-R

Enrollment

258

Registered

2022-02-18

Start date

2022-01-01

Completion date

2026-06-30

Last updated

2026-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Lymphedema

Keywords

Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, axillary lymphatic reflux, axillary vein reflux

Brief summary

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).

Interventions

PROCEDUREBranches Sparing

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

PROCEDURENone Branches Sparing

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
short-term Incidence of lymphedema	1-, 6-, and 12-month	Incidence of upper limb lymphedema on affected side at 1-, 6-, and 12-month after operation
short-term Incidence of dysfunction	1-, 6-, and 12-month	Incidence of upper limb dysfunction on affected side at 1-, 6-, and 12-month after operation

Secondary

Measure	Time frame	Description
long-term Incidence of lymphedema	5 years	Incidence of upper limb lymphedema on affected side 5 years after operation
long-term Incidence of dysfunction	5 years	Incidence of upper limb dysfunction on affected side 5 years after operation

Countries

China

Contacts

STUDY_CHAIRXIANGYUN ZONG, MD, PhD

Shanghai Jiao Tong University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026