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Completed

NCT Number: NCT05078541

Radiofrequency Ablation for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong, Select, 00000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

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

Treatment and study plan

Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor

Procedure

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

Primary outcomes

  1. Volume reduction of Warthin's tumor compared to baseline

    Time frame: 1 year

    Comparison of ultrasound volumetric scan results from 45 weeks post-operative to baseline

Secondary outcomes

  1. Cost and resources

    Time frame: 1 year

    Total cost of the procedure including all related costs

  2. Length of in-patient stay

    Time frame: 1 week

    Total number of in-patient stays recorded as number of days

  3. Operating time

    Time frame: 1 day

    Time required for the procedure recorded as minutes

  4. Perioperative and post-operative complications

    Time frame: 1 year

    Perioperative and post-operative complications in immediate post-operatively and during the follow-up period

  5. Cosmetic score

    Time frame: 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

  6. Visual analogue scale for pain

    Time frame: 1 day

    Collected immediately post-operatively on a scale of 1 - 10, with the higher score being more painful

  7. Visual analogue scale for patient satisfaction

    Time frame: 1 year

    Subjectively graded by the patient on a scale of 1-10 for outcome satisfaction, with the higher score being more satisfactory

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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