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

NCT02691624 | Unknown

• 1 other identifier: BCRLResearch001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema of Upper Arm

Keywords

Lymphedema of Upper Arm; Breast cancer; Breast cancer-related Lymphedema; Lymphoscintigraphy

Outcome Measures

Primary Outcomes (2)

• 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 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

  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 Outcomes (2)

• 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

  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

  in 5 days after operation

Other Outcomes (2)

• Patient upper limb circumference

  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

  2016-2019

Study Arms (2)

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with breast cancer
• There is no metastasis except axillary nodes
• Agree to receive Lymphoscintigraphy of upper extremity

You may not qualify if:

• Pregnancy or lactation
• Inflammatory breast cancer
• Disagree to receive Lymphoscintigraphy of upper extremity
• History of axillary lymph node resection

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (11)

• 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.

  PMID: 25114841 BACKGROUND

• 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.

  PMID: 25169483 BACKGROUND

• 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.

  PMID: 17440362 BACKGROUND

• 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.

  PMID: 22336143 BACKGROUND

• 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.

  PMID: 17479341 BACKGROUND

• 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.

  PMID: 25774851 BACKGROUND

• 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.

  PMID: 22097305 BACKGROUND

• 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.

  PMID: 20101589 BACKGROUND

• 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.

  PMID: 19064976 BACKGROUND

• 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.

  PMID: 23930436 BACKGROUND

• 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.

  PMID: 32482174 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Cancer Lymphedema

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphedema; Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shu Wang

  Peking University People's Hospital Breast Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 25, 2016
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2021
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

CN (1)