Effect of ALND With Vein Branches Reservation 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 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.

Official Title
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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

Conditions
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Breast Cancer Lymphedema

Intervention / Treatment
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* Procedure: axillary lymph node dissection with vein branches reservation
* Procedure: axillary lymph node dissection without vein branches reservation


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 (0-2), 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.

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Branches Sparing<br>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<br>* Spare the vein branches when ALND being performed<br>|
| Active Comparator: None Branches Sparing<br>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<br>* Don't spare the vein branches when ALND being performed<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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Breast Cancer, Axillary Lymph Node Dissection, Post-mastectomy Lymphedema, Upper Limb Dysfunction, Axillary Vein Branches Reservation