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

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2029-04-30

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).

Detailed Description

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Conditions

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Breast Cancer Lymphedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Preponderant lymphatic reflux group

high ratio of axillary lymphatic reflux to axillary vein reflux

Branches Sparing

Intervention Type PROCEDURE

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

None Branches Sparing

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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

None Branches Sparing

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

None Branches Sparing

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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiangyun Zong

OTHER

Sponsor Role lead

Responsible Party

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Xiangyun Zong

Head of Breast Cancer, Principal Investigator, Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Shanghai Fengxian Central Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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JTU-6H-20211230001

Identifier Type: -

Identifier Source: org_study_id

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