Radiofrequency Ablation for Warthin's Tumor

The Chinese University of Hong Kong

Status: Completed

Conditions: Radiofrequency Ablation

Treatments: Procedure: Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT05078541

CRE-2021.412

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years and older

2. Ultrasound scan findings:

   1. Tumor size 2cm-5cm
   2. Tumor located in superficial lobe of parotid gland with epicenter in Parotid tail

3. Tumor is clinically palpable tumor

4. Symptomatic disease with facial asymmetry and cosmetic concerns

5. Diagnosis confirmed by fine needle aspiration x 2

   1. Warthin's tumor
   2. No other parotid pathologies

Exclusion criteria

1. Facial nerve palsy
2. History of parotid surgery
3. History or Symptoms of sialolithiasis
4. Medical facial skin conditions
5. Bleeding tendencies
6. Pregnancy
7. Pacemaker

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

RFA Warthins Tumor Group

Experimental group

Description:

Group of patients who will under RFA for Warthin's tumor.

Treatment:

Procedure: Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor