Shaving as an Safe Alternative to Frozen Section Analysis

November 20, 2025 updated by: Mark Ezzat Gerges

Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery

Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery and aim of study To assess the oncological safety and practicality of tumor bed cavity shaving also aims to evaluate its impact on operative time and overall cost.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer remains the most common malignancy among women worldwide and represents a major health burden. Breast-conserving surgery (BCS) has become the standard of care for early-stage breast cancer, aiming to achieve complete tumor excision with histologically clear margins combined with adjuvant radiotherapy, offers equivalent survival rates to mastectomy in early-stage cases.

. Positive surgical margins are strongly associated with increased rates of local recurrence and frequently necessitate re-excision.

Traditionally, intraoperative frozen section analysis (FSA) has been used to assess margin status. However, this technique has several drawbacks, including:

  • Limited availability in many centers.
  • Requires high-experienced cytopathologists making it challenging in resource-limited places.
  • Adds substantial cost.

  • Time consuming (prolonged operative time).

    • Recently, the tumor bed cavity shaving (TBCS) has been introduced as a more practical alternative technique that can reduce the incidence of positive margins without relying on intraoperative pathology.

tumor bed cavity shaving (TBCS) means additional thin layers of tissue approximately 5:10 mm in thickness are removed circumferentially from the cavity walls .

With many advantages:

  • feasible in centers lacking intraoperative pathological facilities.
  • Time saving (significantly reduces the overall operative time).
  • cost-effectiveness.
  • Technically simple (Easy to perform without the need for specialized equipment or advanced facilities).

  • it represents a suitable option in low- to medium-socioeconomic settings, where resources and advanced intraoperative support may be limited.

    • It is expected to demonstrate comparable oncological safety to Intraoperative Frozen Section Analysis (FSA) in achieving margin negativity with Significant reduction anticipated in Positive margin rates&Re-excision frequency&Operative duration and Overall procedural cost.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Asyut, Egypt, 71515
        • Faculty of Medicine Assiut University
        • Contact:
          • Faculty of medicine Assiut University
          • Phone Number: 088 2411900
          • Email: med@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged ≥18 years.
  • Diagnosed with unifocal, operable invasive breast carcinoma.
  • Suitable for breast-conserving surgery. Criteria:

Exclusion criteria:

-Contraindication of Breast-Conserving Surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tumor bed cavity shaving arm
Patients undergoing breast-conserving surgery will receive intraoperative tumor bed cavity shaving as an alternative approach to ensure clear surgical margins. Additional cavity shavings will be taken circumferentially after the primary lumpectomy specimen. The outcomes will be compared with standard margin assessment methods.
Procedure: Tumor bed cavity shaving

feasible in centers lacking intraoperative pathological facilities.

  • Time saving (significantly reduces the overall operative time).
  • cost-effectiveness.
  • Technically simple (Easy to perform without the need for specialized equipment or advanced facilities).

  • it represents a suitable option in low- to medium-socioeconomic settings, where resources and advanced intraoperative support may be limited.

    • It is expected to demonstrate comparable oncological safety to Intraoperative Frozen Section Analysis (FSA) in achieving margin negativity with Significant reduction anticipated in Positive margin rates&Re-excision frequency&Operative duration and Overall procedural cost.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of positive margins and re-excision within 2 years post-surgery
Time Frame: From time of enrollment of the patient until 2 years post-operative

Percentage of patients whose surgical pathology shows positive margins, and percentage of patients who undergo re-excision. Assessment will be based on histopathology reports and surgical records.

Unit of Measure: percentage number of patients Measurement Tool: Histopathological examination (pathology report) for margin status; surgical database/operative logs for re-excision events.
From time of enrollment of the patient until 2 years post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
- Cost-effectiveness - Facilities availability - Impact on intraoperative time
Time Frame: From enrollment time of the patient until 2 years post operative

  1. Cost-effectiveness Description: Total direct cost incurred per patient from surgery through 2 years of follow-up, including operative costs, pathology, imaging, and any re-operations.

    Unit of Measure: Currency Measurement Tool: cost-analysis using hospital accounting data.

  2. Facilities availability Description: Frequency of use and availability of required surgical infrastructure during the study period.

    Unit of Measure: Number / proportion (for example, number of surgeries per facility per month, or percentage of scheduled surgeries using the study's protocol) Measurement Tool: Hospital operation records, facility logbooks or administrative databases.

  3. Impact on intraoperative time Description: Difference in surgical duration (minutes) between standard procedure and the procedure under study, if applicable.

Unit of Measure: Minutes Measurement Tool: Operative records / anesthesia records. Time Frame: from incision to closure.
From enrollment time of the patient until 2 years post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mark Ezzat Gerges

Investigators

  • Study Chair: Mostafa Thabet, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 15, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBCS as an alternative to FFS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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