Clinical trial NCT05078541: Radiofrequency Ablation for Warthin's Tumor
Official title: A Safety and Feasibility Trial of Ultrasound Guided Radiofrequency Ablation of Parotid Warthin's Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiofrequency Ablation
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Safety and Feasibility Study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Volume reduction of Warthin's tumor compared to baseline
timeFrame: 1 year
Secondary outcomes:
measure: Cost and resources
timeFrame: 1 year
measure: Length of in-patient stay
timeFrame: 1 week
measure: Operating time
timeFrame: 1 day
measure: Perioperative and post-operative complications
timeFrame: 1 year
measure: Cosmetic score
timeFrame: 1 year
measure: Visual analogue scale for pain
timeFrame: 1 day
measure: Visual analogue scale for patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
state: Select
Study officials:
affiliation: Chinese University of Hong Kong
name: David CM Yeung, MBChB
role: PRINCIPAL_INVESTIGATOR
References: