Radiofrequency Ablation for Warthin's Tumor

Not Applicable

Completed

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

• Registration Number: NCT05078541
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-14
• Study Start: 2021-10-20
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-04
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RFA Warthins Tumor Group	Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor	Group of patients who will under RFA for Warthin's tumor.

Primary Outcome Measures

Name	Time	Method
Volume reduction of Warthin's tumor compared to baseline	1 year	Comparison of ultrasound volumetric scan results from 45 weeks post-operative to baseline

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Select, Hong Kong