Impact of Systematic Shaving on Margins

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Surgery; Margin, Tumor-Free
• Intervention / Treatment: Procedure: Margin shaving

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 Type: Interventional
• Enrollment (Estimated): 234
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: amparo garcia-tejedor, MDPhD; Phone Number: 932607695; Email: agarciat@bellvitgehospital.cat

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Recruiting
      • Hospital De Bellvitge
      • Contact: Amparo Garcia-Tejedor, MDPhD; Phone Number: 0034-932607695; Email: agarciat@bellvitgehospital.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: No Shaving; Standard lumpectomy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shaving versus intraoperative pathological study	Assess the possibility of replacing the intraoperative study of the margins with systematic shaving	3 weeks after each surgery

Collaborators and Investigators

• Sponsor: Hospital Universitari de Bellvitge
• Investigators: Principal Investigator: Amparo Garcia Tejedor, MDPhD, Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): October 16, 2026

Study Registration Dates

• First Submitted: March 11, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): March 23, 2023

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Breast Neoplasms; Margins of Excision
• Other Study ID Numbers: PR275/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No