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NCT Number: NCT05782686

Impact of Systematic Shaving on Margins

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.

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Key information

Conditions

Margin, Tumor-Free Breast Cancer Breast Diseases Breast Neoplasms Margins of Excision Morphological and Microscopic Findings Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location status: Recruiting

Location contact

Amparo Garcia-Tejedor, MDPhD

CONTACT

[email protected]

0034-932607695

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;

Treatment and study plan

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.

Primary outcomes

  1. Margin involvement

    Time frame: 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

  2. Re-interventions

    Time frame: 3 weeks after each surgery

    Demonstrate the reduction of second surgeries to widen affected margins in breast conserving surgery with the shaving technique

Secondary outcomes

  1. Shaving versus intraoperative pathological study

    Time frame: 3 weeks after each surgery

    Assess the possibility of replacing the intraoperative study of the margins with systematic shaving

Study contacts

Contact information is provided by the study sponsor or research team.

amparo garcia-tejedor, MDPhD

CONTACT

[email protected]

932607695

Sponsors and collaborators

Lead sponsor

Hospital Universitari de Bellvitge

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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