Radiofrequency Ablation for Warthin's Tumor

NCT ID: NCT05078541

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-20
• Study Completion Date: 2022-12-15

Brief Summary

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

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.

Conditions

Radiofrequency Ablation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RFA Warthins Tumor Group

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

Group Type: EXPERIMENTAL

Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor

Intervention Type: PROCEDURE

The Procedure

1. Injection of local subcutaneous and pericapsular anaesthesia

2. Needle radiofrequency ablation under ultrasound guidance

3. Patients should communicate with operating surgeon upon excessive heat or pain

4. The procedure usually lasts 30-45 minutes

Interventions

Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor

The Procedure

1. Injection of local subcutaneous and pericapsular anaesthesia

2. Needle radiofrequency ablation under ultrasound guidance

3. Patients should communicate with operating surgeon upon excessive heat or pain

4. The procedure usually lasts 30-45 minutes

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

David Yeung

Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David CM Yeung, MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, Select, Hong Kong

Countries

Hong Kong

Other Identifiers

CRE-2021.412

Identifier Type: -

Identifier Source: org_study_id