Clinical trial NCT02691624: Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation
Official title: Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphedema of Upper Arm
Keywords: Lymphedema of Upper Arm
Breast cancer
Breast cancer-related Lymphedema
Lymphoscintigraphy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 breast cancer patients treated in Peking University People's Hospital Breast Center and agree to receive lymphoscintigraphy of upper extremity.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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 biopsy
timeFrame: During operation
measure: Number of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissection
timeFrame: During operation
Secondary outcomes:
measure: 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
timeFrame: in 5 days after operation
measure: 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
timeFrame: in 5 days after operation
Other outcomes:
measure: Patient upper limb circumference
timeFrame: 1 day before operation and 6 months, 1 year, 1.5year, 2 year, 2.5 year, 3 year, 4 year after operation
measure: Patients' bioimpedence value
timeFrame: 2016-2019
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital Breast Center
name: Shu Wang
role: PRINCIPAL_INVESTIGATOR
References:
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