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

Lymphedema of Upper Arm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02691624
• Other study ID #: BCRLResearch001
• Status: Active, not recruiting
• Start date: October 2015
• Est. completion date: December 2021

Study information

• Verified date: December 2021
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Lymphedema
• Lymphedema of Upper Arm

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

Borri M, Schmidt MA, Gordon KD, Wallace TA, Hughes JC, Scurr ED, Koh DM, Leach MO, Mortimer PS. Quantitative Contrast-Enhanced Magnetic Resonance Lymphangiography of the Upper Limbs in Breast Cancer Related Lymphedema: An Exploratory Study. Lymphat Res Biol. 2015 Jun;13(2):100-6. doi: 10.1089/lrb.2014.0039. Epub 2015 Mar 16. — View Citation

Fu MR. Breast cancer-related lymphedema: Symptoms, diagnosis, risk reduction, and management. World J Clin Oncol. 2014 Aug 10;5(3):241-7. doi: 10.5306/wjco.v5.i3.241. Review. — View Citation

International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2013 Consensus Document of the International Society of Lymphology. Lymphology. 2013 Mar;46(1):1-11. Review. — View Citation

Liu NF, Lu Q, Liu PA, Wu XF, Wang BS. Comparison of radionuclide lymphoscintigraphy and dynamic magnetic resonance lymphangiography for investigating extremity lymphoedema. Br J Surg. 2010 Mar;97(3):359-65. doi: 10.1002/bjs.6893. — View Citation

Liu NF, Lu Q, Liu PA, Yan ZX, Wu XF. [Comparison study of radionuclide lymphoscintigraphy and dynamic magnetic resonance lymphangiography for the diagnosis of extremity lymphedema]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2011 Jul;27(4):241-5. Chinese. — View Citation

Norman SA, Localio AR, Potashnik SL, Simoes Torpey HA, Kallan MJ, Weber AL, Miller LT, Demichele A, Solin LJ. Lymphedema in breast cancer survivors: incidence, degree, time course, treatment, and symptoms. J Clin Oncol. 2009 Jan 20;27(3):390-7. doi: 10.1200/JCO.2008.17.9291. Epub 2008 Dec 8. — View Citation

Pavlista D, Eliska O. Analysis of direct oil contrast lymphography of upper limb lymphatics traversing the axilla -- a lesson from the past -- contribution to the concept of axillary reverse mapping. Eur J Surg Oncol. 2012 May;38(5):390-4. doi: 10.1016/j.ejso.2012.01.010. Epub 2012 Feb 14. — View Citation

Suami H, Taylor GI, Pan WR. The lymphatic territories of the upper limb: anatomical study and clinical implications. Plast Reconstr Surg. 2007 May;119(6):1813-1822. doi: 10.1097/01.prs.0000246516.64780.61. — View Citation

Thompson M, Korourian S, Henry-Tillman R, Adkins L, Mumford S, Westbrook KC, Klimberg VS. Axillary reverse mapping (ARM): a new concept to identify and enhance lymphatic preservation. Ann Surg Oncol. 2007 Jun;14(6):1890-5. Epub 2007 May 4. — View Citation

Zhu YQ, Xie YH, Liu FH, Guo Q, Shen PP, Tian Y. Systemic analysis on risk factors for breast cancer related lymphedema. Asian Pac J Cancer Prev. 2014;15(16):6535-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient upper limb circumference	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
Other	Patients' bioimpedence value	The bioelectrical impedance measurement was performed during follow-up	2016-2019
Primary	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	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 ? detector during operation. The number and relationship with the sentinel lymph node can be measured.	During operation
Primary	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	Patients enrolled undertake upper limb lymphoscintigraphy before axillary lymph node dissection(ALND).The lymph nodes draining upper extremity lymph can be detected by ? detector in the tissue resected and axilla after operation. The number of them can be measured.	During operation
Secondary	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	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
Secondary	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	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