Impact of Systematic Shaving on Margins

Not Applicable

Recruiting

• Conditions: Breast Cancer; Surgery; Margin, Tumor-Free
• Interventions: Procedure: Margin shaving

• Registration Number: NCT05782686
• Lead Sponsor: Hospital Universitari de Bellvitge

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2020-10-07
• Study First Submitted: 2023-03-11
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-03-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-14
• Primary Completion: 2024-06-16
• Study Completion: 2025-10-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 234

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Shaving	Margin shaving	Standard lumpectomy
Shaving	Margin shaving	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.

Primary Outcome Measures

Name	Time	Method
Margin involvement	3 weeks after each surgery	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
Re-interventions	3 weeks after each surgery	Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique

Secondary Outcome Measures

Name	Time	Method
Shaving versus intraoperative pathological study	3 weeks after each surgery	Assess the possibility of replacing the intraoperative study of the margins with systematic shaving

Trial Locations

Locations (1)

Hospital de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain