Radiofrequency Ablation for Warthin's Tumor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Safety and Feasibility Trial of Ultrasound Guided Radiofrequency Ablation of Parotid Warthin's Tumor

Conditions
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Radiofrequency Ablation

Intervention / Treatment
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* Procedure: Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Facial nerve palsy History of parotid surgery History or Symptoms of sialolithiasis Medical facial skin conditions Bleeding tendencies Pregnancy Pacemaker

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Safety and Feasibility Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RFA Warthins Tumor Group<br>Group of patients who will under RFA for Warthin's tumor. | Procedure: Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor<br>* The Procedure Injection of local subcutaneous and pericapsular anaesthesia Needle radiofrequency ablation under ultrasound guidance Patients should communicate with operating surgeon upon excessive heat or pain The procedure usually lasts 30-45 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume reduction of Warthin's tumor compared to baseline | Comparison of ultrasound volumetric scan results from 45 weeks post-operative to baseline | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost and resources | Total cost of the procedure including all related costs | 1 year | 
| Length of in-patient stay | Total number of in-patient stays recorded as number of days | 1 week | 
| Operating time | Time required for the procedure recorded as minutes | 1 day | 
| Perioperative and post-operative complications | Perioperative and post-operative complications in immediate post-operatively and during the follow-up period | 1 year | 
| Cosmetic score | A subjective score of cosmesis graded by the patient on a scale of 1 - 4, with the higher score having worse cosmetic outcomes | 1 year | 
| Visual analogue scale for pain | Collected immediately post-operatively on a scale of 1 - 10, with the higher score being more painful | 1 day | 
| Visual analogue scale for patient satisfaction | Subjectively graded by the patient on a scale of 1-10 for outcome satisfaction, with the higher score being more satisfactory | 1 year |