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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Total drainage volume
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Total drainage volume
时间窗: on the first, second, third, and fourth postoperative days.
Placement of a drainage tube in the surgical area, with postoperative drainage volumes recorded on the first, second, third, and fourth days.
1-year tumor recurrence rate
时间窗: 1 year
Calculate the recurrence rate of the tumor one year after surgery.
次要结局
- Blood magnesium ions levels(at one month and six months after the operation)
- Serum alanine aminotransferase (ALT)(at one month and six months after the operation)
- Serum creatinine(at one month and six months after the operation)
- Estimated glomerular filtration rate (eGFR）(at one month and six months after the operation)