A Safety and Feasibility Trial of Ultrasound Guided Radiofrequency Ablation of Parotid Warthin's Tumor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Volume reduction of Warthin's tumor compared to baseline
研究概览
简要总结
This study is a safety and feasibility study to determine if ultrasound guided radiofrequency ablation of parotid Warthin's tumor under local anesthesia is a safe and effective procedure compared to Parotidectomy while using less resources.
详细描述
Radiofrequency ablation is minimally invasive and is used in benign disease, including thyroid nodules, head and neck nodules, and vascular malformations, as well as some malignant tumors. For patients unable to or unwilling to undergo surgical resection, real-time ultrasound guided radiofrequency ablation for parotid Warthin's Tumor would be a further option besides observation alone.
Twenty patients with Warthin's tumor from the ENT Head and Neck Surgery out-patient clinic at Prince of Wales Hospital will be recruited. The patient will first be asked if they wanted intervention for their condition of Warthin's Tumor. Parotidectomy will first be offered. If the patient opted for intervention but declines parotidectomy, then ultrasound guided RFA will be offered.
The 2019 - 2020 Parotidectomy for Warthin's tumor internal audit will be used as a historical comparison to the ultrasound guided RFA group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years and older
- •Ultrasound scan findings:
- •Tumor size 2cm-5cm
- •Tumor located in superficial lobe of parotid gland with epicenter in Parotid tail
- •Tumor is clinically palpable tumor
- •Symptomatic disease with facial asymmetry and cosmetic concerns
- •Diagnosis confirmed by fine needle aspiration x 2
- •Warthin's tumor
- •No other parotid pathologies
排除标准
- •Facial nerve palsy
- •History of parotid surgery
- •History or Symptoms of sialolithiasis
- •Medical facial skin conditions
- •Bleeding tendencies
结局指标
主要结局
Volume reduction of Warthin's tumor compared to baseline
时间窗: 1 year
Comparison of ultrasound volumetric scan results from 45 weeks post-operative to baseline
次要结局
- Length of in-patient stay(1 week)
- Cosmetic score(1 year)
- Operating time(1 day)
- Visual analogue scale for patient satisfaction(1 year)
- Cost and resources(1 year)
- Perioperative and post-operative complications(1 year)
- Visual analogue scale for pain(1 day)
研究者
David Yeung
Resident
Chinese University of Hong Kong