Radiofrequency Ablation for Warthin's Tumor

Radiofrequency Ablation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05078541
• Other study ID #: CRE-2021.412
• Status: Completed
• Phase: N/A
• Start date: October 20, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Radiofrequency Ablation

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong	Select

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cost and resources	Total cost of the procedure including all related costs	1 year
Secondary	Length of in-patient stay	Total number of in-patient stays recorded as number of days	1 week
Secondary	Operating time	Time required for the procedure recorded as minutes	1 day
Secondary	Perioperative and post-operative complications	Perioperative and post-operative complications in immediate post-operatively and during the follow-up period	1 year
Secondary	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
Secondary	Visual analogue scale for pain	Collected immediately post-operatively on a scale of 1 - 10, with the higher score being more painful	1 day
Secondary	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