Assessment of Breast Cancer-Related Arm Lymphedema

Study Overview
=================
Brief Summary
-----------------
Lymphedema is a serious complication of breast cancer treatment. Reported prevalence of lymphedema following treatment for breast cancer varies, ranging from 7-45%. The reason for the wide variation in the reported incidence of lymphedema is the different measurement techniques used and the absence of an agreed diagnostic criteria. Nowadays, the common method include limb circumference measurement、volume measurement、bioimpedance spectroscopy (BIS) and self-report. Each of these methods has advantages and disadvantages. A variety of publications have demonstrated the ability of bioimpedance to diagnose subclinical lymphedema. As a new method for detecting lymphedema, some study have also shown indocyanine green（ICG）lymphography can have a certain value for the detection of subclinical lymphedema. Early detection can reduce the incidence of late-stage lymphedema in postoperative patients. Therefore, we want to explore the ability of these methods. We are going to perform baseline arm circumference measurements and bioelectrical impedance measurements for all preoperative breast cancer patients in our center. In addition, the arm circumference measurement、volume measurement、bioimpedance spectroscopy (BIS) 、self-report and indocyanine green (ICG) lymphography will be performed on patients who go to the lymphedema clinic after breast cancer surgery. First, we want to establish the threshold and reference value range based on the impedance value of patients with lymphedema and people without lymphedema.Second, we are going to examine the relationship between the most commonly used methods of lymphedema and also to test which method is more sensitive for the diagnosis of clinical and subclinical lymphedema. Finally, we want to explore the ability of ICG lymphography in detecting sub-clinical lymphedema.

Detailed Description
-----------------
Breast cancer is a common malignant disease that threatens the health of women. As a serious complication of breast cancer treatment, lymphedema is caused by chronic accumulation of lymph fluid in the interstitial spaces of the affected limb or surrounding areas. Reported prevalence of lymphedema following treatment for breast cancer varies, ranging from 7-45%. One reason for the wide variation in the reported incidence of lymphedema is the different measurement techniques used and the absence of an agreed diagnostic criteria. Nowadays, the common method include limb circumference measurement、volume measurement、bioimpedance spectroscopy (BIS) and self-report. Each of these methods has advantages and disadvantages. A variety of publications have demonstrated the ability of bioimpedance to diagnose subclinical lymphedema. As a new method for detecting lymphedema, some study have also shown indocyanine green（ICG）lymphography can have a certain value for the detection of subclinical lymphedema. Early detection can reduce the incidence of late-stage lymphedema in postoperative patients. Therefore, we want to explore the ability of these methods. We are going to perform baseline arm circumference measurements and bioelectrical impedance measurements for all preoperative breast cancer patients in our center. In addition, the arm circumference measurement、volume measurement、bioimpedance spectroscopy (BIS) 、self-report and indocyanine green (ICG) lymphography will be performed on patients who go to the lymphedema clinic after breast cancer surgery.First, we want to establish the threshold and reference value range based on the impedance value of patients with lymphedema and people without lymphedema.Second, we are going to examine the relationship between the most commonly used methods of lymphedema and also to test which method is more sensitive for the diagnosis of clinical and subclinical lymphedema. Finally, we want to explore the ability of ICG lymphography in detecting sub-clinical lymphedema.

Official Title
-----------------
Assessment of Breast Cancer-Related Arm Lymphedema-Comparison of Traditional Measurement Methods and Indocyanine Green（ICG）Lymphography

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: ICG lymphography、CM、VD、Bioelectrical impedance technology、self-report
* Diagnostic Test: Bioelectrical impedance technology、CM


Participation Criteria
=================
Eligibility Criteria
-----------------
The eligibility criteria for patients who visit the clinic: Inclusion Criteria: Patients with breast cancer who underwent axillary surgery. Patients who have complaints about upper extremity lymphedema and are willing to undergo examination. Sign the informed consent. Exclusion Criteria: Bilateral breast cancer. A history of allergy to contrast agents. There are arteriovenous thrombosis in the affected limb. Regional lymph node recurrence Did not sign informed consent. Serious heart, brain and other diseases. The primary lymphatic system diseases (such as lymphatic leakage). Only one side of the limb received ICG angiography. The eligibility criteria for preoperative subjects diagnosed with breast cancer: Inclusion Criteria: • Preoperative subjects diagnosed with breast cancer at our breast center. Exclusion Criteria: • We strictly excluded all possible causes of lymphedema. Subjects whose clinical stage of lymph node is N2 or higher were excluded. Subjects with lymphedema -related diseases or kidney disease, inflammatory breast cancer, a history of axillary surgery, radiotherapy to the upper limbs or the chest wall, soft tissue infection, pregnancy, congestive heart-failure, administration of diuretics (which may have significantly changed the hydration status) and implanted devices (e.g., pacemakers), were also excluded.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who visit clinic<br>Postoperative patients who have undergone axillary surgery for breast cancer and went to clinic due to complaints of upper limb discomfort.（The expected number of subjects in this group is 300） | Diagnostic Test: ICG lymphography、CM、VD、Bioelectrical impedance technology、self-report<br>* All of these methods are used for patients visiting the lymphedema clinic to assess whether they have developed lymphedema.<br>* Other names: VD: volume displacement;|
| Preoperative breast cancer patients<br>Preoperative subjects diagnosed with breast cancer were enrolled as non-lymphedema group. （The expected number of subjects in this group is 1300） | Diagnostic Test: Bioelectrical impedance technology、CM<br>* These two methods are routine evaluation methods for breast cancer patients before surgery<br>* Other names: CM: circumference measurement;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of indocyanine green (ICG) lymphography | Sensitivity means the ability of detecting patients with true lymphedema. Specificity means the ability of detecting non-lymphedema patients. | 2017-2022 | 
| The incidence of lymphedema | The incidence of lymphedema assessed by different methods when patients first visit clinic | 2017-2022 | 
| The cutoff value of BIS | studies on the threshold value established by Inbody 720 device have been extremely limited. We aimed to determine its reference range and cutoff values. | 2017-2022 | 
| The occurrence of lymphedema after follow-up | Patients who don't develop lymphedema when the first visit to the lymphedema clinic, the occurrence of lymphedema after follow-up. | 2017-2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphedema, Breast cancer, ICG lymphography, Bioelectrical impedance technology