Effect of the Axillary Lymphatic /Vein Reflux Ratio on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer
NCT ID: NCT05246592
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
258 participants
OBSERVATIONAL
2022-01-01
2029-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Preponderant lymphatic reflux group
high ratio of axillary lymphatic reflux to axillary vein reflux
Branches Sparing
The patients will undergo axillary lymph node dissection with preserved axillary vein branches
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
Branches Sparing
The patients will undergo axillary lymph node dissection with preserved axillary vein branches
None Branches Sparing
The patients will undergo axillary lymph node dissection without preserved axillary vein branches
Interventions
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Branches Sparing
The patients will undergo axillary lymph node dissection with preserved axillary vein branches
None Branches Sparing
The patients will undergo axillary lymph node dissection without preserved axillary vein branches
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
69 Years
ALL
No
Sponsors
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Xiangyun Zong
OTHER
Responsible Party
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Xiangyun Zong
Head of Breast Cancer, Principal Investigator, Clinical Professor
Principal Investigators
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XIANGYUN ZONG, MD, PhD
Role: STUDY_CHAIR
Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Shanghai Fengxian Central Hospital
Shanghai, , China
Countries
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Other Identifiers
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JTU-6H-20211230001
Identifier Type: -
Identifier Source: org_study_id
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