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Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation

Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02691624
Enrollment
100
Registered
2016-02-25
Start date
2015-10-31
Completion date
2021-12-31
Last updated
2021-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema of Upper Arm

Keywords

Lymphedema of Upper Arm, Breast cancer, Breast cancer-related Lymphedema, Lymphoscintigraphy

Brief summary

Lymphoscintigraphy is a noninvasive,accurate and effective imaging modality. In this study, it is used to investigate the imaging characteristics of patients'upper limb lymphatic drainage before operation, and the influence of operation on it.

Detailed description

The global burden of breast cancer continues to increase largely because of the aging and growth of the world population. More than 1.38 million women worldwide were estimated to be diagnosed with breast cancer in 2008, accounting for 23% of all diagnosed cancers in women. Given that the 5-year survival rate for breast cancer is now 90%, experiencing breast cancer is ultimately about quality of life. Women treated for breast cancer are facing a life-time risk of developing lymphedema, a chronic condition that occurs in up to 40% of this population and negatively affects breast cancer survivors' quality of life. It's becoming more and more important to do more research on the breast cancer-related lymphedema. Axillary reverse mapping (ARM) is a technique used to map arm lymphatic drainage during axillary lymph node dissection (ALND) and/or sentinel lymph node dissection (SLND). It's necessary for the investigators to understand the participants' upper limb lymphatic drainage before operation and what the investigators have done on it during operation. It can be easy to understand the influence of operation on the participants' upper limb lymphatic drainage, the possibility and safety of reserving lymph nodes draining the upper extremity lymph.

Interventions

None listed

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

For inclusion in the study patients must fulfil all of the following criteria: 1. Diagnosed with breast cancer 2. There is no metastasis except axillary nodes 3. Agree to receive Lymphoscintigraphy of upper extremity

Exclusion criteria

Any of the following is regarded as a criterion for exclusion from the study: 1. Pregnancy or lactation 2. Inflammatory breast cancer 3. Disagree to receive Lymphoscintigraphy of upper extremity 4. History of axillary lymph node resection

Design outcomes

Primary

MeasureTime frameDescription
Number and relationship with the sentinel lymph node of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsyDuring operationPatients enrolled undertake upper limb lymphoscintigraphy before sentinel lymph node biopsy(SLNB).The lymph nodes draining upper extremity lymph will contain 99mTc-Dextran and can be detected by γ detector during operation. The number and relationship with the sentinel lymph node can be measured.
Number of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissectionDuring operationPatients enrolled undertake upper limb lymphoscintigraphy before axillary lymph node dissection(ALND).The lymph nodes draining upper extremity lymph can be detected by γ detector in the tissue resected and axilla after operation. The number of them can be measured.

Secondary

MeasureTime frameDescription
Pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsyin 5 days after operationThe pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsy will be reported in 5 days after operation
Pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissectionin 5 days after operationThe pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissection will be reported in 5 days after operation

Other

MeasureTime frameDescription
Patient upper limb circumference1 day before operation and 6 months, 1 year, 1.5year, 2 year, 2.5 year, 3 year, 4 year after operationThe patients' upper limb circumference will be measured on 1 day before operation and 6 months, 1 year, 1.5year, 2 year, 2.5 year, 3 year, 4 year after operation
Patients' bioimpedence value2016-2019The bioelectrical impedance measurement was performed during follow-up

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026