Is Breast Massage Necessary to Find Sentinel Lymph Node?
NCT ID: NCT05663112
Last Updated: 2023-09-25
Study Results
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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COMPLETED
NA
77 participants
INTERVENTIONAL
2021-12-06
2023-07-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Arm with massage
5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied.
Drug: Isosulfan Blue 5 ml
Sentinel lymph node biopsy
Sentinel lymph node biopsy will be performed.
Breast massage
Breast massage will be performed for a duration of 5 minutes.
Blue dye injection
Isosulfan blue dye will be injected in the subareolar region of the breast
Arm without massage
5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied.
Drug: Isosulfan Blue 5 ml
Sentinel lymph node biopsy
Sentinel lymph node biopsy will be performed.
Blue dye injection
Isosulfan blue dye will be injected in the subareolar region of the breast
Interventions
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Sentinel lymph node biopsy
Sentinel lymph node biopsy will be performed.
Breast massage
Breast massage will be performed for a duration of 5 minutes.
Blue dye injection
Isosulfan blue dye will be injected in the subareolar region of the breast
Eligibility Criteria
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Inclusion Criteria
* participants voluntarily participated in the clinical trial and signed informed consent
Exclusion Criteria
* had neoadjuvant chemotherapy
* had clinical hints of axillary lymph node metastasis
18 Years
ALL
No
Sponsors
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Celal Bayar University
OTHER
Responsible Party
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Sezgi Erel
Research assistant, MD
Principal Investigators
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Teoman Coskun, Prof.
Role: STUDY_DIRECTOR
Celal Bayar University Department of General Surgery
Locations
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Celal Bayar University
Manisa, Yunusemre, Turkey (Türkiye)
Countries
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References
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Diaz NM, Vrcel V, Centeno BA, Muro-Cacho C. Modes of benign mechanical transport of breast epithelial cells to axillary lymph nodes. Adv Anat Pathol. 2005 Jan;12(1):7-9. doi: 10.1097/01.pap.0000151267.34438.a1.
Shenoy V, Ravichandran D, Ralphs DN. Is massage following dye injection necessary in sentinel node biopsy in breast cancer? Breast. 2002 Jun;11(3):273-4. doi: 10.1054/brst.2002.0415.
Bass SS, Cox CE, Salud CJ, Lyman GH, McCann C, Dupont E, Berman C, Reintgen DS. The effects of postinjection massage on the sensitivity of lymphatic mapping in breast cancer. J Am Coll Surg. 2001 Jan;192(1):9-16. doi: 10.1016/s1072-7515(00)00771-7.
Related Links
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Is massage following dye injection necessary in sentinel node biopsy in breast cancer?
The Effects of Postinjection Massage on the Sensitivity of Lymphatic Mapping in Breast Cancer
Modes of Benign Mechanical Transport of Breast Epithelial Cells to Axillary Lymph Nodes
Other Identifiers
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20.478.486
Identifier Type: -
Identifier Source: org_study_id
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