Impact of Systematic Shaving on Margins

NCT05782686 | Recruiting

• 1 other identifier: PR275/20
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Margin, Tumor-Free; Breast Cancer; Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Shaving versus intraoperative pathological study

  3 weeks after each surgery

Study Arms (2)

Shaving

EXPERIMENTAL

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

No Shaving

ACTIVE COMPARATOR

Standard lumpectomy

Procedure: Margin shaving

Interventions

Margin shaving PROCEDURE

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.

No Shaving; Shaving

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Male patients;
• Patients with a history of ipsilateral breast cancer.
• Oncoplastic that includes flaps
• Multifocality or multicentricity;
• Pregnant or lactating patient;
• Stage IV patients;
• Patients eligible for mastectomy;

Sponsors & Collaborators

• Hospital Universitari de Bellvitge: lead

Study Sites (1)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

MeSH Terms

Conditions

Margins of Excision; Breast Neoplasms

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amparo Garcia Tejedor, MDPhD

  Hospital de Bellvitge. Instituto de Investigación Biomédica de Bellvitge (IDIBELL)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

amparo garcia-tejedor, MDPhD

CONTACT

932607695; agarciat@bellvitgehospital.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomization will be performed by another investigator outside the operating room after lumpectomy.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: March 11, 2023
• First Posted: March 23, 2023
• Study Start: October 7, 2020
• Primary Completion (Estimated): June 16, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)