Radiofrequency AblationNCT05078541
Radiofrequency Ablation for Warthin's Tumor
A study testing Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor in people with Radiofrequency Ablation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiofrequency Ablation
- What is being tested?
- Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Oct 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Diagnosis confirmed by fine needle aspiration x 2
- Warthin's tumor
- No other parotid pathologies
Who cannot join
- Facial nerve palsy
- History of parotid surgery
- History or Symptoms of sialolithiasis
- Medical facial skin conditions
- Bleeding tendencies
- Pregnancy
- Pacemaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Safety and Feasibility Trial of Ultrasound Guided Radiofrequency Ablation of Parotid 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.
Read the 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.
- Conditions
- Radiofrequency Ablation
- Being tested
- Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's TumorProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| RFA Warthins Tumor Group | Experimental | Group of patients who will under RFA for Warthin's tumor. Receives: Procedure: Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume reduction of Warthin's tumor compared to baseline
Comparison of ultrasound volumetric scan results from 45 weeks post-operative to baseline
Measured: 1 year
Secondary outcomes (7)
Cost and resources
Total cost of the procedure including all related costs
Measured: 1 year
Length of in-patient stay
Total number of in-patient stays recorded as number of days
Measured: 1 week
Operating time
Time required for the procedure recorded as minutes
Measured: 1 day
Perioperative and post-operative complications
Perioperative and post-operative complications in immediate post-operatively and during the follow-up period
Measured: 1 year
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
Measured: 1 year
Visual analogue scale for pain
Collected immediately post-operatively on a scale of 1 - 10, with the higher score being more painful
Measured: 1 day
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start20 Oct 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiofrequency AblationStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Safety and Feasibility Study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Yeung, Chinese University of Hong Kong
- Investigators
- David CM Yeung, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078541
- Sponsor's protocol ID
- CRE-2021.412
- Status last verified
- Feb 2023
- First submitted
- 4 Oct 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Feasibility Trial of Ultrasound Guided Radiofrequency Ablation of Parotid Warthin's Tumor
- ClinicalTrials.gov ID
- NCT05078541
- Acronym / sponsor ID
- CRE-2021.412
- Conditions
- Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Safety and Feasibility Study
| Arm | Type | Receives |
|---|---|---|
| RFA Warthins Tumor Group | Experimental | Procedure: Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's TumorGroup of patients who will under RFA for Warthin's tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years and older
- Ultrasound scan findings:
- Tumor is clinically palpable tumor
- Symptomatic disease with facial asymmetry and cosmetic concerns
- Diagnosis confirmed by fine needle aspiration x 2
Key exclusion criteria (7 listed)
- Facial nerve palsy
- History of parotid surgery
- History or Symptoms of sialolithiasis
- Medical facial skin conditions
- Bleeding tendencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's TumorThe 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 | Procedure or surgery | RFA Warthins Tumor Group |
Primary outcome
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
7 secondary outcomes
Cost and resources
Time frame: 1 year
Length of in-patient stay
Time frame: 1 week
Operating time
Time frame: 1 day
Perioperative and post-operative complications
Time frame: 1 year
Cosmetic score
Time frame: 1 year
Visual analogue scale for pain
Time frame: 1 day
Visual analogue scale for patient satisfaction
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David CM Yeung, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor in people with Radiofrequency Ablation, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume reduction of Warthin's tumor compared to baseline (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.