The Safety and Efficacy of Combined Microwave Ablation During Limb-sparing Surgery in High-risk Soft Tissue Sarcoma Patients

NCT ID: NCT06802510

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-21
• Study Completion Date: 2024-12-31

Brief Summary

Soft tissue sarcoma (STS) is a rare, aggressive malignancy with a high risk of recurrence when invading surrounding structures, and the optimal treatment strategy for safe surgical margin is still unclear. This study aimed to evaluate the safety and efficacy of combined local inactivation by ablation in STS during limb-sparing surgery in high-risk STS patients.

Detailed Description

Soft tissue sarcoma (STS) is a rare, aggressive malignancy with a high risk of recurrence when invading surrounding structures, and the optimal treatment strategy for safe surgical margin is still unclear. This study aimed to evaluate the safety and efficacy of combined local inactivation by ablation in STS during limb-sparing surgery in high-risk STS patients. Investigators collected data retrospectively from participants diagnosed with soft tissue sarcoma who were treated at a tertiary medical institution from January 1, 2018, to December 31, 2022. This study was approved by the hospital's Ethics Committee (XJS2022-101-01), and all participants provided written informed consent. The participants were divided into two groups (MWA and control group). The MWA group received surgical resection combined with local lesion inactivation by MWA, while the control group underwent standard surgical resection alone. Non-specified sarcomas are treated with the AI(Doxorubicin+Ifosfamide) chemotherapy regimen, while Ewing's sarcoma is treated with the standard recommended VDC ((Vincristine + Doxorubicin + Cyclophosphamide)/IE(Ifosfamide + Etoposide) chemotherapy regimen.

Conditions

Sarcoma; Microwave; Ablation Techniques

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MWA group

The MWA group received surgical resection combined with local lesion inactivation by MWA

Group Type: EXPERIMENTAL

Microwave Ablation

Intervention Type: PROCEDURE

The MWA group followed a similar resection procedure as the control group. The area of ablation was evaluated strictly by radiologists and surgeons according to the following criteria: 1) Areas of tumor response, progression, or suspicious invasion (intermediate-high signal and edema range in T2) were assessed. Wide margins of at least 2-3 cm or more were obtained over the normal tissue around the tumor. Ablation margins were covered using a microwave ablation array with antennas (Microwave Ablation System BD-GT, Baird Medical LLC), aimed at completely inactivating the tumor in situ. Ablation needles were strategically arranged to form a matrix covering the target zone. The ablation time and power were determined based on the extent of the lesion, ensuring the temperature of the ablation area remained between 70-80°C. A 50 ml syringe was used to continuously drip and spray ice-cold saline to keep surrounding tissue temperatures below 40-43°C.

Control group

The control group received standard surgical resection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Microwave Ablation

The MWA group followed a similar resection procedure as the control group. The area of ablation was evaluated strictly by radiologists and surgeons according to the following criteria: 1) Areas of tumor response, progression, or suspicious invasion (intermediate-high signal and edema range in T2) were assessed. Wide margins of at least 2-3 cm or more were obtained over the normal tissue around the tumor. Ablation margins were covered using a microwave ablation array with antennas (Microwave Ablation System BD-GT, Baird Medical LLC), aimed at completely inactivating the tumor in situ. Ablation needles were strategically arranged to form a matrix covering the target zone. The ablation time and power were determined based on the extent of the lesion, ensuring the temperature of the ablation area remained between 70-80°C. A 50 ml syringe was used to continuously drip and spray ice-cold saline to keep surrounding tissue temperatures below 40-43°C.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Pathologically confirmed soft tissue sarcoma (FNCLCC grade G2-G3);

2. MRI/CT confirmed tumor invasion beyond anatomical compartments, joint involvement, or encroachment on surrounding tissues (bones, muscle, etc.);

3. After being fully informed of the risks, the patient strongly refuses amputation or wide resection, which leads to irreversible impaired function.

4. Good physical condition, able to tolerate surgery;

Exclusion Criteria

1. Patients with distant metastasis at the time of initial diagnosis;

2. Patients with missing clinical or follow-up data.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu Zhang, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Guangdong provincial people's hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

MWASTS001

Identifier Type: -

Identifier Source: org_study_id