Shaving as an Safe Alternative to Frozen Section Analysis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tumor bed cavity shaving.
- Who it may be relevant to
- Registry conditions: Early Stage Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery
Overview
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.
Interventions
- 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 Sec
Primary outcome measures
- 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]
Secondary outcome measures (1)
- - Cost-effectiveness - Facilities availability - Impact on intraoperative time [Time frame: From enrollment time of the patient until 2 years post operative]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of Medicine Assiut University — Asyut
Identifiers
NCT: NCT07244588 · TBCS as an alternative to FFS