Shaving as an Safe Alternative to Frozen Section Analysis

Mark Ezzat Gerges

Status: Not yet enrolling

Conditions: Early Stage Breast Cancer

Treatments: Procedure: Tumor bed cavity shaving

Study type: Interventional

Funder types: Other

Identifiers

NCT07244588

TBCS as an alternative to FFS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Tumor bed cavity shaving arm

Experimental group

Description:

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.

Treatment:

Procedure: Tumor bed cavity shaving