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

December 12, 2021 updated by: Peking University People's Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: During operation
Patients 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.
During operation
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
Time Frame: During operation
Patients 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.
During operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: in 5 days after operation
The 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
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 dissection
Time Frame: in 5 days after operation
The 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
in 5 days after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient upper limb circumference
Time Frame: 1 day before operation and 6 months, 1 year, 1.5year, 2 year, 2.5 year, 3 year, 4 year after operation
The 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
1 day before operation and 6 months, 1 year, 1.5year, 2 year, 2.5 year, 3 year, 4 year after operation
Patients' bioimpedence value
Time Frame: 2016-2019
The bioelectrical impedance measurement was performed during follow-up
2016-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Shu Wang, Peking University People's Hospital Breast Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 20, 2016

First Posted (Estimate)

February 25, 2016

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 12, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCRLResearch001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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