Breast Cancer Clinical Trial
Official title:
Is Breast Massage Necessary to Find Sentinel Lymph Node After Isosulfan Blue Injection in Patients With Breast Cancer? A Prospective Randomized Study.
Verified date | September 2023 |
Source | Celal Bayar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Sentinel lymph node biopsy is important for staging in patients with breast cancer and changes the way of surgery. One of the most commonly used methods to find the sentinel lymph node during surgery is to apply blue dye around the areola and then search for the sentinel lymph node. Breast massage is recommended following administration of the blue dye. However, the necessity of this massage is controversial. In this study, investigators will try to find out whether massage of the breast after blue dye injection has any positive effect on finding the sentinel lymph node.
Status | Completed |
Enrollment | 77 |
Est. completion date | July 6, 2023 |
Est. primary completion date | July 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - the diagnosis of breast cancer by biopsy - participants voluntarily participated in the clinical trial and signed informed consent Exclusion Criteria: - had previous sentinel lymph node biopsy or axillary surgery - had neoadjuvant chemotherapy - had clinical hints of axillary lymph node metastasis |
Country | Name | City | State |
---|---|---|---|
Turkey | Celal Bayar University | Manisa | Yunusemre |
Lead Sponsor | Collaborator |
---|---|
Celal Bayar University |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sentinel lymph node detection rate | Participants will be followed until the pathology report is finalized | 2 weeks |
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