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

NCT06802510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-01-31

No results posted yet for this study

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.

Conditions

  • Sarcoma
  • Microwave
  • Ablation Techniques

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-21
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06802510 on ClinicalTrials.gov