Radiofrequency Ablation for Warthin's Tumor
Primary Purpose
Radiofrequency Ablation
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor
Sponsored by
About this trial
This is an interventional treatment trial for Radiofrequency Ablation
Eligibility Criteria
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
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RFA Warthins Tumor Group
Arm Description
Group of patients who will under RFA for Warthin's tumor.
Outcomes
Primary Outcome Measures
Volume reduction of Warthin's tumor compared to baseline
Comparison of ultrasound volumetric scan results from 45 weeks post-operative to baseline
Secondary Outcome Measures
Cost and resources
Total cost of the procedure including all related costs
Length of in-patient stay
Total number of in-patient stays recorded as number of days
Operating time
Time required for the procedure recorded as minutes
Perioperative and post-operative complications
Perioperative and post-operative complications in immediate post-operatively and during the follow-up period
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
Visual analogue scale for pain
Collected immediately post-operatively on a scale of 1 - 10, with the higher score being more painful
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
Full Information
NCT ID
NCT05078541
First Posted
October 4, 2021
Last Updated
February 4, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05078541
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiofrequency Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Safety and Feasibility Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RFA Warthins Tumor Group
Arm Type
Experimental
Arm Description
Group of patients who will under RFA for Warthin's tumor.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor
Intervention Description
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 Outcome Measure Information:
Title
Volume reduction of Warthin's tumor compared to baseline
Description
Comparison of ultrasound volumetric scan results from 45 weeks post-operative to baseline
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Cost and resources
Description
Total cost of the procedure including all related costs
Time Frame
1 year
Title
Length of in-patient stay
Description
Total number of in-patient stays recorded as number of days
Time Frame
1 week
Title
Operating time
Description
Time required for the procedure recorded as minutes
Time Frame
1 day
Title
Perioperative and post-operative complications
Description
Perioperative and post-operative complications in immediate post-operatively and during the follow-up period
Time Frame
1 year
Title
Cosmetic score
Description
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 year
Title
Visual analogue scale for pain
Description
Collected immediately post-operatively on a scale of 1 - 10, with the higher score being more painful
Time Frame
1 day
Title
Visual analogue scale for patient satisfaction
Description
Subjectively graded by the patient on a scale of 1-10 for outcome satisfaction, with the higher score being more satisfactory
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David CM Yeung, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
State/Province
Select
ZIP/Postal Code
00000
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
No
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Radiofrequency Ablation for Warthin's Tumor
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