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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
98
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.
Guangdong provincial people's hospital
Guangzhou, Guangdong, China
1-year tumor recurrence rate
Calculate the recurrence rate of the tumor one year after surgery.
Time frame: 1 year
Total drainage volume
Placement of a drainage tube in the surgical area, with postoperative drainage volumes recorded on the first, second, third, and fourth days.
Time frame: on the first, second, third, and fourth postoperative days.
Blood magnesium ions levels
Measure the magnesium ions levels in the blood before surgery, one month after surgery, and six months after surgery. Magnesium ions in the blood are measured in mmol/L. The normal range of serum magnesium is 0.75 to 1.25 mmol/L. Hypermagnesemia is defined as serum magnesium levels greater than 1.25 mmol/L, and hypomagnesemia is defined as serum magnesium levels less than 0.75 mmol/L. Assess the impact of the degradation of the biodegradable enzyme-metal clip on the magnesium ions in the blood, and thereby evaluate its safety for the human body.
Time frame: at one month and six months after the operation
Serum alanine aminotransferase (ALT)
Venous blood is collected and sent to Guangdong Provincial People's Hospital Department of Laboratory Medicine for analysis one month and six months after surgery. The normal range of serum alanine aminotransferase (ALT) is 7 to 40 U/L. When ALT is beyond the normal range, we consider that the biodegradable magnesium metal clip has caused liver damage during its degradation process, thus evaluating the safety of the metal clip.
Time frame: at one month and six months after the operation
Serum creatinine
For normal renal function, the serum creatinine levels are 0.6 - 1.2 mg/dL (53 - 106 µmol/L) for adult males and 0.5 - 1.1 mg/dL (44 - 97 µmol/L) for adult females. Mild renal impairment is indicated by serum creatinine levels of 1.3 - 1.9 mg/dL (115 - 168 µmol/L) in males and 1.2 - 1.8 mg/dL (106 - 159 µmol/L) in females. Moderate renal impairment is reflected by levels of 2.0 - 4.0 mg/dL (177 - 354 µmol/L) in males and 1.9 - 4.0 mg/dL (168 - 354 µmol/L) in females. Severe renal impairment is indicated by serum creatinine levels of 4.1 - 8.0 mg/dL (362 - 707 µmol/L) for both genders. End-stage renal disease (ESRD) is classified by serum creatinine levels greater than 8.0 mg/dL (\>707 µmol/L) for both genders. These classifications may vary based on specific clinical standards or guidelines and should be considered in conjunction with other clinical indicators and professional medical judgment.
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Time frame: at one month and six months after the operation
Estimated glomerular filtration rate (eGFR）
The estimated glomerular filtration rate (eGFR) is a key indicator of kidney function, used to classify chronic kidney disease (CKD) into different stages: Stage 1: eGFR ≥ 90 mL/min/1.73 m², indicating normal kidney function. Stage 2: eGFR 60-89 mL/min/1.73 m², representing mildly decreased kidney function. Stage 3: Divided into two sub-stages: Stage 3a: eGFR 45-59 mL/min/1.73 m², indicating moderate kidney impairment. Stage 3b: eGFR 30-44 mL/min/1.73 m², reflecting more significant kidney dysfunction. Stage 4: eGFR 15-29 mL/min/1.73 m², showing severe kidney impairment. Stage 5: eGFR \< 15 mL/min/1.73 m² or requiring dialysis, indicating kidney failure. These eGFR values help in evaluating kidney function and determining the appropriate treatment approach, with specific adjustments based on clinical guidelines and individual patient factors.
Time frame: at one month and six months after the operation