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Набор скоро начнётся NCT06550765

Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors

Без фазы С лечением Sarcoma, Soft Tissue Sarcoma, Spindle Cell

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: Biodegradable Magnesium Metal Clips.
Кому может быть актуально
Состояния в реестре: Sarcoma, Soft Tissue, Sarcoma, Spindle Cell. Базовые параметры: 18 лет — 65 лет · Все.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors: A Single-Center, Randomized Controlled Study

Обзор

To verify and evaluate the safety and efficacy of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors.

Подробное описание

The purpose of this study is to verify and evaluate the safety and effectiveness of biodegradable magnesium metal clips in the surgical margins of radical surgery for bone and soft tissue malignant tumors. The study will be divided into two groups:

Experimental Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.

Control Group: The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Electrocautery and suture ligation are used to handle the tumor bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.

Вмешательства

  • Устройство Biodegradable Magnesium Metal Clips
    The tumor lesion area is exposed using conventional methods, and the tumor segment is resected according to the principles of tumor-free operation. Magnesium metal closure clips are used to clamp the tumor blood vessels, osteoperiosteal bleeding points, and other bleeding sites. The lesion area is thoroughly rinsed to ensure no active bleeding, and routine necessary reconstruction is performed.

Первичные конечные точки

  • 1-year tumor recurrence rate [Срок оценки: 1 year]
  • Total drainage volume [Срок оценки: on the first, second, third, and fourth postoperative days.]
Вторичные конечные точки (4)
  • Blood magnesium ions levels [Срок оценки: at one month and six months after the operation]
  • Serum alanine aminotransferase (ALT) [Срок оценки: at one month and six months after the operation]
  • Serum creatinine [Срок оценки: at one month and six months after the operation]
  • Estimated glomerular filtration rate (eGFR） [Срок оценки: at one month and six months after the operation]

Критерии участия

Критерии включения

  • Participants must be of either gender, aged between 18 and 65 years;
  • Diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma, liposarcoma, or other bone and soft tissue sarcomas;
  • Must have undergone standard chemotherapy and require en bloc resection;
  • Participants must voluntarily enroll and sign an informed consent form; willing to closely cooperate with the physician to comply with all study requirements, including participation in all follow-up and assessments.

Критерии исключения

  • Severe dysfunction of the heart, liver, kidney, lung, or brain.
  • Pregnant women or women who are breastfeeding.
  • History of autoimmune disease, HIV infection, history of immunosuppressive disorder, or currently taking immunosuppressive drugs.
  • History of syphilis (Treponema pallidum), active infection with hepatitis B or C, and positive for verified antigens.
  • Participation in any other clinical study currently or within 3 months prior to the screening visit.
  • Patients have any other conditions that the researcher deems unsuitable for the study. Age is between 18 to 75 years old.

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
  • Guangdong provincial people's hospital — Гуанчжоу

Идентификаторы

NCT: NCT06550765 · PureMgBoneCuttingEdge

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗