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Идёт набор NCT07507890

Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer

Без фазы С лечением Breast Cancer - Ductal Carcinoma in Situ (DCIS) Breast Cancer

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: Endoscopic Nipple-Sparing Mastectomy (E-NSM).
Кому может быть актуально
Состояния в реестре: Breast Cancer - Ductal Carcinoma in Situ (DCIS), 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
Италия
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

MINI-B - Minimally Invasive Endoscopic Mastectomy Using a Single Axillary Incision in Breast Cancer Patients: a Prospective Cohort Study

Обзор

This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing direct-to-implant breast reconstruction. The study will assess procedural feasibility, completeness of resection, short-term postoperative complications, and patient-reported outcomes

Подробное описание

MINI-B is a single-institution prospective study conducted at the Breast Surgery Unit of Candiolo Cancer Center, Istituto di Candiolo FPO-IRCCS, Torino, Italy. The study will enroll 10 consecutive adult female patients with early-stage invasive breast cancer or ductal carcinoma in situ who are candidates for nipple-sparing mastectomy with direct-to-implant reconstruction and are suitable for a minimally invasive approach. The investigated procedure is endoscopic nipple-sparing mastectomy performed through a single hidden axillary incision using a standardized technique modeled on the robotic nipple-sparing mastectomy procedure already in use at the institution. The study will evaluate feasibility through technical and perioperative parameters, assess resection completeness by margin status, record postoperative complications over 3 months, and collect patient-reported quality-of-life data using BREAST-Q/EORTC questionnaires.

Вмешательства

  • Процедура Endoscopic Nipple-Sparing Mastectomy (E-NSM)
    Endoscopic nipple-sparing mastectomy performed through a single extra-mammary axillary incision using a standardized minimally invasive surgical technique; immediate direct-to-implant reconstruction will be performed according to institutional practice.

Первичные конечные точки

  • Successful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery [Срок оценки: During the index surgical procedure]
  • Total operative time [Срок оценки: During the index surgical procedure]
  • Negative surgical margin rate [Срок оценки: From surgery to final pathology assessment, up to 30 days after surgery]
Вторичные конечные точки (7)
  • Length of postoperative hospitalization [Срок оценки: From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days]
  • Participants with at least 1 postoperative complication [Срок оценки: From the date of surgery to 3 months after surgery]
  • Participants with at least 1 major postoperative complication [Срок оценки: From the date of surgery to 3 months after surgery]
  • BREAST-Q Satisfaction With Breasts score [Срок оценки: Baseline (preoperative assessment) and 3 months after surgery]
  • BREAST-Q Reconstruction Module Psychosocial Well-Being score [Срок оценки: Baseline (preoperative assessment) and 3 months after surgery]
  • BREAST-Q Reconstruction Module Physical Well-Being: Chest score [Срок оценки: Baseline (preoperative assessment) and 3 months after surgery]
  • BREAST-Q Reconstruction Module Sexual Well-Being score [Срок оценки: Baseline (preoperative assessment) and 3 months after surgery]

Критерии участия

Критерии включения

  • Female participants aged 18 years or older.
  • Diagnosis of early-stage invasive breast cancer or ductal carcinoma in situ, including multifocal or multicentric disease.
  • Candidate for nipple-sparing mastectomy with immediate direct-to-implant reconstruction.
  • Small- to medium-sized breasts with ptosis grade 2 or less.
  • Written informed consent provided.

Критерии исключения

  • Preoperative evidence of skin involvement, nipple-areola complex involvement, lymph-node metastases, inflammatory breast cancer, Paget's disease, mesenchymal breast tumors, or recurrent breast cancer.
  • Previous ipsilateral breast surgery.
  • Previous thoracic radiation therapy.
  • Heavy smoking (>20 cigarettes/day), uncontrolled diabetes mellitus, or body mass index >30.
  • ASA score 3 or higher.
  • Ongoing pregnancy

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

Италия · 1 центр
  • Breast Unit — Candiolo

Идентификаторы

NCT: NCT07507890 · 003-FPO25

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗