Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biodegradable Magnesium Metal Clips.
- Who it may be relevant to
- Registry conditions: Sarcoma, Soft Tissue, Sarcoma, Spindle Cell. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Device 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.
Primary outcome measures
- 1-year tumor recurrence rate [Time frame: 1 year]
- Total drainage volume [Time frame: on the first, second, third, and fourth postoperative days.]
Secondary outcome measures (4)
- Blood magnesium ions levels [Time frame: at one month and six months after the operation]
- Serum alanine aminotransferase (ALT) [Time frame: at one month and six months after the operation]
- Serum creatinine [Time frame: at one month and six months after the operation]
- Estimated glomerular filtration rate (eGFR） [Time frame: at one month and six months after the operation]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong provincial people's hospital — Guangzhou
Identifiers
NCT: NCT06550765 · PureMgBoneCuttingEdge