Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07244588

Shaving as an Safe Alternative to Frozen Section Analysis

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Assiut University

Asyut, 71515, Egypt

Location contact

Faculty of medicine Assiut University

CONTACT

[email protected]

088 2411900

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Tumor bed cavity shaving

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. - Cost-effectiveness - Facilities availability - Impact on intraoperative time

    Time frame: From enrollment time of the patient until 2 years post operative

    • 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.

    • 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.

    • 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.

Study contacts

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

Mark Ezzat Gerges, Resident doctor

CONTACT

[email protected]

+201229385677

Nagm elden Abu elnaga, Ph D

CONTACT

[email protected]

+201015417979

Sponsors and collaborators

Lead sponsor

Mark Ezzat Gerges

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 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.

Published trials that share one or more normalized conditions with this study.