Shaving as an Safe Alternative to Frozen Section Analysis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Tumor bed cavity shaving.
- Кому может быть актуально
- Состояния в реестре: Early Stage Breast Cancer. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Tumor Bed Cavity Shaving as an Oncologically Safe Alternative to Frozen Section Analysis in Breast-Conserving Surgery
Обзор
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.
Подробное описание
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.
Вмешательства
- Процедура 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
Первичные конечные точки
- Rate of positive margins and re-excision within 2 years post-surgery [Срок оценки: From time of enrollment of the patient until 2 years post-operative]
Вторичные конечные точки (1)
- - Cost-effectiveness - Facilities availability - Impact on intraoperative time [Срок оценки: From enrollment time of the patient until 2 years post operative]
Критерии участия
Критерии включения
- Female patients aged ≥18 years.
- Diagnosed with unifocal, operable invasive breast carcinoma.
- Suitable for breast-conserving surgery. Criteria:
Критерии исключения
-Contraindication of Breast-Conserving Surgery.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Египет · 1 центр
- Faculty of Medicine Assiut University — Asyut
Идентификаторы
NCT: NCT07244588 · TBCS as an alternative to FFS