Impact of Systematic Shaving on Margins

Breast Cancer Clinical Trial

Official title:

Reduction of Affected Margins in Conservative Surgery for Breast Cancer: Impact of Systematic Shaving in the Operating Room

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05782686
• Other study ID #: PR275/20
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: October 16, 2025

Study information

• Verified date: August 2023
• Source: Hospital Universitari de Bellvitge
• Contact: amparo garcia-tejedor, MDPhD
• Phone: 932607695
• Email: agarciat[@]bellvitgehospital.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: October 16, 2025
• Est. primary completion date: June 16, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Margin, Tumor-Free
• Surgery

Intervention

Procedure:
• Margin shaving
In both cohorts, an intraoperative study of the margins will be carried out, and enlargement of those margins that are affected will be carried out as indicated by the pathologist. Subsequently, shaving is performed in case of being randomized to the study group or surgery is completed in the control group.

Locations

Country	Name	City	State
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Margin involvement	To compare the number of cases with affected margins in the definitive pathological anatomy, of the cases with intraoperative systematic shaving versus the group of no shaving	3 weeks after each surgery
Primary	Re-interventions	Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique	3 weeks after each surgery
Secondary	Shaving versus intraoperative pathological study	Assess the possibility of replacing the intraoperative study of the margins with systematic shaving	3 weeks after each surgery