Radiofrequency Ablation for Warthin's Tumor

NCT05078541 | Completed

• 1 other identifier: CRE-2021.412
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Cost and resources

  1 year

• Length of in-patient stay

  1 week

• Operating time

  1 day

• Perioperative and post-operative complications

  1 year

• Cosmetic score

  1 year

Study Arms (1)

RFA Warthins Tumor Group

EXPERIMENTAL

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

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

Interventions

Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor 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

RFA Warthins Tumor Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Ultrasound scan findings:
• Tumor size 2cm-5cm
• Tumor located in superficial lobe of parotid gland with epicenter in Parotid tail
• Tumor is clinically palpable tumor
• Symptomatic disease with facial asymmetry and cosmetic concerns
• Diagnosis confirmed by fine needle aspiration x 2
• Warthin's tumor
• No other parotid pathologies

You may not qualify if:

• Facial nerve palsy
• History of parotid surgery
• History or Symptoms of sialolithiasis
• Medical facial skin conditions
• Bleeding tendencies
• Pregnancy
• Pacemaker

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Select, 00000, Hong Kong

Location

Study Officials

• David CM Yeung, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: Safety and Feasibility Study

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 14, 2021
• Study Start: October 20, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)