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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05663112
Other study ID # 20.478.486
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 6, 2021
Est. completion date July 6, 2023

Study information

Verified date September 2023
Source Celal Bayar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This research is a prospective randomized study. Patients will be randomized by number-drawing method. Patients with BMI>30 and age>65 will be equally distributed to the experimental and active comparator arms. Under general anesthesia patients will be injected with 5 ml of isosulfan blue into the subareolar region. In one group, breast massage will be applied for 5 minutes. In the other group no massage will be applied. Surgical team will wait for a duration of 5 minutes for the self distribution of the blue dye.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Turkey Celal Bayar University Manisa Yunusemre

Sponsors (1)

Lead Sponsor Collaborator
Celal Bayar University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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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