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

P

Peking University

Status

Unknown

Conditions

Lymphedema of Upper Arm

Study type

Observational

Funder types

Other

Identifiers

NCT02691624
BCRLResearch001

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

sentinel lymph node biopsy
Description:
Patients of the group is diagnosed with breast cancer and receive lymphoscintigraphy before operation, and will receive sentinel lymph node biopsy
axillary lymph node dissection
Description:
Patients of the group is diagnosed with breast cancer and receive lymphoscintigraphy before operation, and will receive axillary lymph node dissection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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