Effect of ALND With Vein Branches Reservation on Postoperative Upper Limb Edema and Dysfunction in Breast Cancer
NCT ID: NCT05120180
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
NA
258 participants
INTERVENTIONAL
2022-01-03
2029-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Branches Sparing
The patients in this arm will undergo axillary lymph node dissection with preserved axillary vein branches
axillary lymph node dissection with vein branches reservation
Spare the vein branches when ALND being performed
None Branches Sparing
The patients in this arm will undergo axillary lymph node dissection without preserved axillary vein branches
axillary lymph node dissection without vein branches reservation
Don't spare the vein branches when ALND being performed
Interventions
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axillary lymph node dissection with vein branches reservation
Spare the vein branches when ALND being performed
axillary lymph node dissection without vein branches reservation
Don't spare the vein branches when ALND being performed
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 (0-2),
* 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
* 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, M.D., Ph.D.P
Role: STUDY_CHAIR
Shanghai Jiao Tong University School of Medicine
Locations
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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-20211011001
Identifier Type: -
Identifier Source: org_study_id
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