Shaving as an Safe Alternative to Frozen Section Analysis

NCT ID: NCT07244588

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Early Stage Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tumor bed cavity shaving

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mark Ezzat Gerges

OTHER

Sponsor Role: lead

Responsible Party

Mark Ezzat Gerges

Resident Physician at General surgery department Assiut University Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mostafa Thabet

Role: STUDY_CHAIR

Assiut University

Locations

Faculty of Medicine Assiut University

Asyut, , Egypt

Countries

Egypt

Central Contacts

Mark Ezzat Gerges, Resident doctor

Role: CONTACT

markezzat99@gmail.com

+201229385677

Nagm elden Abu elnaga, Ph D

Role: CONTACT

nagmdairy@gmail.com

+201015417979

Facility Contacts

Faculty of medicine Assiut University

Role: primary

med@aun.edu.eg

088 2411900

Other Identifiers

TBCS as an alternative to FFS

Identifier Type: -

Identifier Source: org_study_id