Impact of Systematic Shaving on Margins

Catalan Institute of Health

Status: Enrolling

Conditions: Breast Cancer; Surgery; Margin, Tumor-Free

Treatments: Procedure: Margin shaving

Study type: Interventional

Funder types: Other

Identifiers

NCT05782686

PR275/20

Details and patient eligibility

About

The objective of this clinical trial is to demonstrate the reduction of positive margins in the definitive pathology of patients undergoing breast-conserving surgery with the systematic shaving technique compared to conventional surgery, and the reduction of second interventions for margin enlargement.

Full description

Patients with breast cancer who undergo breast-conserving surgery are randomized in the operating room after lumpectomy into 2 groups of 117 patients each: shaving/no-shaving (standard surgery).

Enrollment: 234 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Breast-conserving surgery.
2. Imaging diagnosis as the only breast tumor focus according to mammography, breast ultrasound and/or nuclear magnetic resonance;
3. Pathological diagnosis of carcinoma in situ or infiltrating
4. Oncoplastic without associated flaps;

Exclusion criteria

1. Male patients;
2. Patients with a history of ipsilateral breast cancer.
3. Oncoplastic that includes flaps
4. Multifocality or multicentricity;
5. Pregnant or lactating patient;
6. Stage IV patients;
7. Patients eligible for mastectomy;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

234 participants in 2 patient groups

Shaving

Experimental group

Description:

Subsequent to lumpectomy, a circumferential enlargement of all lumpectomy margins, including lateral, medial, superior, inferior, anterior, and posterior, approximately 5-10mm thick, will be resected.

Treatment:

Procedure: Margin shaving

No Shaving

Active Comparator group

Description:

Standard lumpectomy

Treatment:

Procedure: Margin shaving