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Набор скоро начнётся NCT06671249

Comparing the Safety and Cosmetic Outcomes Between Laparoscopic Versus Traditional Open Breast-conserving Surgery

Без фазы С лечением 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: Laparoscopic breast-conserving surgery, Traditional open breast-conserving surgery.
Кому может быть актуально
Состояния в реестре: 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
Китай
Следующий шаг
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Официальное название

A Multicenter, Open and Prospective Randomized Controlled Trial Comparing the Safety and Cosmetic Outcomes of Laparoscopic Breast-conserving Surgery Versus Traditional Open Breast-conserving Surgery.

Обзор

In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.

Подробное описание

In recent years, laparoscopic breast cancer surgery has received wide attention. It has advantages of minimal invasiveness, clear anatomical exposure, and good aesthetic effects. Based on these advantages, we propose whether laparoscopy is suitable for breast-conserving surgery for breast cancer. The standard procedure of laparoscopic breast-conserving surgery is unclear. More high-quality clinical studies are required to ensure the efficiency of cure. Also, less scars and breast preservation has becoming more and more important for patients' acceptance to the treatment. Therefore, we intend to conduct a multi-center, open, productive, randomized controlled study comparing the safety and cosmetic effects of endoscopic breast-conserving with traditional open breast-conserving surgery.

Вмешательства

  • Процедура Laparoscopic breast-conserving surgery
    Use laparoscopic surgery to treat breast cancer patients who want and have the opportunity to preserve their breast
  • Процедура Traditional open breast-conserving surgery
    Treat breast cancer patients who want and have the opportunity to preserve their breast with traditional open breast-conserving surgery.

Первичные конечные точки

  • breast appearance satisfaction [Срок оценки: 2 years]
  • breast aesthetic scores [Срок оценки: 2 years]
Вторичные конечные точки (3)
  • Complications [Срок оценки: 1 year]
  • Quality of Life [Срок оценки: 1 year]
  • local recurrence rate [Срок оценки: 2 years]

Критерии участия

Критерии включения

  • Female over the age of 18
  • Preoperative pathologically confirmed invasive breast cancer or ductal carcinoma in situ
  • Clinical classification T1, T2 (maximum tumor diameter ≤5cm)
  • Single-center tumor (preoperative confirmation by B-ultrasound, MRI and other imaging examinations)
  • No clinical or imaging evidence of distant metastasis
  • Able and willing to sign informed consent

Критерии исключения

  • Tumor in the lower inner quadrant
  • Tumor in multiple quadrants
  • Imaging or intraoperative pathology indicates tumor invasion of the nipple areola, skin, or pectoralis major
  • Locally advanced breast cancer patients are undergoing neoadjuvant therapy
  • Tumor in multiple quadrants
  • Have been participating in other clinical trials, which may affect the participation in this trial
  • Previous history of breast cancer (patients with recurrence after ipilateral breast-conserving surgery)
  • Pregnant and lactating women
  • Patients with severe cardiopulmonary disease or severely impaired lung function are not suitable for surgical establishment of an air cavity

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Xiaochen Wang — Ханчжоу

Идентификаторы

NCT: NCT06671249 · 2024-1251

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗