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Assessment of Breast Cancer-Related Arm Lymphedema

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03978754
Enrollment
1600
Registered
2019-06-07
Start date
2017-10-01
Completion date
2022-01-31
Last updated
2021-12-07

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

Conditions

Breast Cancer

Keywords

Lymphedema, Breast cancer, ICG lymphography, Bioelectrical impedance technology

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.

Interventions

DIAGNOSTIC_TESTICG lymphography、CM、VD、Bioelectrical impedance technology、self-report

All of these methods are used for patients visiting the lymphedema clinic to assess whether they have developed lymphedema.

DIAGNOSTIC_TESTBioelectrical impedance technology、CM

These two methods are routine evaluation methods for breast cancer patients before surgery

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Sensitivity and specificity of indocyanine green (ICG) lymphography2017-2022Sensitivity means the ability of detecting patients with true lymphedema. Specificity means the ability of detecting non-lymphedema patients.
The incidence of lymphedema2017-2022The incidence of lymphedema assessed by different methods when patients first visit clinic
The cutoff value of BIS2017-2022studies on the threshold value established by Inbody 720 device have been extremely limited. We aimed to determine its reference range and cutoff values.
The occurrence of lymphedema after follow-up2017-2022Patients who don't develop lymphedema when the first visit to the lymphedema clinic, the occurrence of lymphedema after follow-up.

Countries

China

Contacts

Primary Contactliu siyao
dr.liusiyao@pku.edu.cn+86 18801229921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026