Safety and Efficacy of Degradable Magnesium Metal Clips in Surgical Margins of Radical Surgery for Malignant Bone and Soft Tissue Tumors

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcoma, Soft Tissue; Sarcoma, Spindle Cell
• Intervention / Treatment: Device: Biodegradable Magnesium Metal Clips

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.

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Zhang, Ph.D.; Phone Number: 8613602744495; Email: luck_2001@126.com
• Study Contact Backup: Name: Yonghan Chen, Bachelor; Phone Number: 8615602384042; Email: chen_yh2000@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 516008
      • Guangdong Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The tumor lesion area is exposed using conventional surgery 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.
Experimental: Magnesium metal closure 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 25, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 21, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Soft Tissue sarcoma; biodegradable magnesium metal
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Sarcoma; Soft Tissue Neoplasms
• Other Study ID Numbers: PureMgBoneCuttingEdge

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Researchers can request access from the corresponding author upon reasonable inquiry.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No