Radiofrequency Ablation for Warthin's Tumor

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

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.

Study Overview

• Status: Completed
• Conditions: Radiofrequency Ablation
• Intervention / Treatment: Procedure: Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Select
    • Hong Kong, Select, Hong Kong, 00000
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RFA Warthins Tumor Group; Group of patients who will under RFA for Warthin's tumor.	Procedure: Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: David CM Yeung, MBChB, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2021
• Primary Completion (ACTUAL): December 15, 2022
• Study Completion (ACTUAL): December 15, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (ACTUAL): October 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 4, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Complex and Mixed; Adenolymphoma
• Other Study ID Numbers: CRE-2021.412

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No