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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Breast Cancer Lymphedema

Intervention / Treatment
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* Procedure: Branches Sparing
* Procedure: None Branches Sparing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preponderant lymphatic reflux group<br>high ratio of axillary lymphatic reflux to axillary vein reflux | Procedure: Branches Sparing<br>* The patients will undergo axillary lymph node dissection with preserved axillary vein branches<br>Procedure: None Branches Sparing<br>* The patients will undergo axillary lymph node dissection without preserved axillary vein branches<br>|
| Preponderant venous reflux group<br>low ratio of axillary lymphatic reflux to axillary vein reflux | Procedure: Branches Sparing<br>* The patients will undergo axillary lymph node dissection with preserved axillary vein branches<br>Procedure: None Branches Sparing<br>* The patients will undergo axillary lymph node dissection without preserved axillary vein branches<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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axillary vein reflux, Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, axillary lymphatic reflux