Prince of Wales Hospital
Hong Kong, Select, 00000
NCT Number: NCT05078541
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Hong Kong, Select, 00000
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Procedure
Time frame: 1 year
Comparison of ultrasound volumetric scan results from 45 weeks post-operative to baseline
Time frame: 1 year
Total cost of the procedure including all related costs
Time frame: 1 week
Total number of in-patient stays recorded as number of days
Time frame: 1 day
Time required for the procedure recorded as minutes
Time frame: 1 year
Perioperative and post-operative complications in immediate post-operatively and during the follow-up period
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
Time frame: 1 day
Collected immediately post-operatively on a scale of 1 - 10, with the higher score being more painful
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
Chinese University of Hong Kong
Other
A Safety and Feasibility Trial of Ultrasound Guided Radiofrequency Ablation of Parotid Warthin's Tumor
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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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