Clinical trial NCT06550765: Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcoma, Soft Tissue
Sarcoma, Spindle Cell
Keywords: Soft Tissue sarcoma
biodegradable magnesium metal
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. Participants must be of either gender, aged between 18 and 65 years;
2. Diagnosis must be confirmed pathologically as osteosarcoma, synovial sarcoma, liposarcoma, or other bone and soft tissue sarcomas;
3. Must have undergone standard chemotherapy and require en bloc resection;
4. 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:

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

Primary outcomes:
measure: 1-year tumor recurrence rate
timeFrame: 1 year
measure: Total drainage volume
timeFrame: on the first, second, third, and fourth postoperative days.
Secondary outcomes:
measure: Blood magnesium ions levels
timeFrame: at one month and six months after the operation
measure: Serum alanine aminotransferase (ALT)
timeFrame: at one month and six months after the operation
measure: Serum creatinine
timeFrame: at one month and six months after the operation
measure: Estimated glomerular filtration rate (eGFR）
timeFrame: at one month and six months after the operation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong provincial people's hospital
state: Guangdong
Study officials:
References: