Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors
NCT Number: NCT06550765
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Sarcoma, Soft Tissue|Sarcoma, Spindle Cell
Interventions: DEVICE: Biodegradable Magnesium Metal Clips
Sponsor: Guangdong Provincial People's Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 98
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-25
Completion Date: 2027-12-31
Locations: Guangdong provincial people's hospital, Guangzhou, Guangdong, 516008, China

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.

Primary Outcome Measures: 1-year tumor recurrence rate, Calculate the recurrence rate of the tumor one year after surgery., 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., on the first, second, third, and fourth postoperative days.
Secondary Outcome Measures: 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., 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., 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., 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., at one month and six months after the operation