Is Breast Massage Necessary to Find Sentinel Lymph Node?

Celal Bayar University

Status: Completed

Conditions: Breast Cancer; Sentinel Lymph Node

Treatments: Procedure: Blue dye injection; Procedure: Breast massage; Procedure: Sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT05663112

20.478.486

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Arm with massage

Active Comparator group

Description:

5 ml of isosulfan blue will be injected into the subareolar region. 5-minutes massage will be applied. Drug: Isosulfan Blue 5 ml

Treatment:

Procedure: Blue dye injection

Procedure: Breast massage

Procedure: Sentinel lymph node biopsy

Arm without massage

Experimental group

Description:

5 ml of isosulfan blue will be injected into the subareolar region. No massage will be applied. Drug: Isosulfan Blue 5 ml

Treatment:

Procedure: Blue dye injection

Procedure: Sentinel lymph node biopsy