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

NCT ID: NCT02691624

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lymphedema of Upper Arm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shu Wang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital Breast Center

Locations

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Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 25114841 (View on PubMed)

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. doi: 10.7314/apjcp.2014.15.16.6535.

Reference Type BACKGROUND
PMID: 25169483 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17440362 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22336143 (View on PubMed)

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. doi: 10.1245/s10434-007-9412-x. Epub 2007 May 4.

Reference Type BACKGROUND
PMID: 17479341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25774851 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22097305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20101589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19064976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23930436 (View on PubMed)

Liu S, Wang N, Gao P, Liu P, Yang H, Xie F, Wang S, Liu M, Wang S. Using the axillary reverse mapping technique to screen breast cancer patients with a high risk of lymphedema. World J Surg Oncol. 2020 Jun 1;18(1):118. doi: 10.1186/s12957-020-01886-9.

Reference Type DERIVED
PMID: 32482174 (View on PubMed)

Other Identifiers

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BCRLResearch001

Identifier Type: -

Identifier Source: org_study_id

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