Outcomes of radiofrequency ablation and microwave ablation for T1N0M0 papillary thyroid carcinoma
| ISRCTN | ISRCTN85501259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85501259 |
- Submission date
- 24/10/2023
- Registration date
- 25/10/2023
- Last edited
- 25/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Ultrasound (US)-guided thermal ablation, including radiofrequency ablation (RFA), microwave ablation (MWA), laser ablation, and high-intensity focused ultrasound, are the local application of extreme temperatures to induce tumor apoptosis (cell death) and coagulative necrosis, and have been used for the treatment of tumors. In the last few years, these minimally invasive treatments have been considered potential alternatives for patients with T1N0M0 papillary thyroid carcinoma (PTC) who are at surgical risk or are unwilling to undergo surgery or active surveillance. RFA and MWA were the most frequently used and are differentiated by their methods of generating heat. This study aims to compare the clinical outcomes of patients with solitary T1N0M0 PTC who underwent RFA or MWA.
Who can participate?
Patients aged 18 to 80 years with T1N0M0 PTC
What does the study involve?
RFA or MWA was considered only in patients with T1N0M0 PTC unsuitable for surgery or rejected surgery/active surveillance clearly. The patients underwent RFA or MWA by US physicians with over 10 years of experience in interventional thyroid US-performed ablation. The RFA or MWA was selected according to the physician’s experience and modality preference. After treatment, follow-ups were performed at 1, 3, 6, 12, and every 6-12 months thereafter. Ultrasound and contrast-enhanced ultrasound were performed at each follow-up evaluation. Chest CT was performed annually to monitor distant metastases. The study lasts 2 years in total.
What are the possible benefits and risks of participating?
Whether one of the two treatments (RFA, MWA) is superior to the other can be answered by the information obtained from this study. There are no expected risks of physical injury or harm.
Where is the study run from?
First Affiliated Hospital of Chinese PLA General Hospital (China)
When is the study starting and how long is it expected to run for?
July 2018 to September 2021
Who is funding the study?
First Affiliated Hospital of Chinese PLA General Hospital (China)
Who is the main contact?
Dr Lin Yan, gemma-y@163.com
Contact information
Public, Scientific, Principal Investigator
No.28 Fuxing Road
Beijing
100853
China
 ORCID ID |
0000-0002-5944-8198 |
|---|---|
| Phone | +86 (0)1066937394 |
| lyk301@yeah.net |
Study information
| Study design | Single-center retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Comparative outcomes of radiofrequency ablation vs microwave ablation for patients with T1N0M0 papillary thyroid carcinoma |
| Study objectives | Radiofrequency ablation (RFA) and microwave ablation (MWA) had comparable clinical outcomes for the treatment for patients with T1N0M0 papillary thyroid carcinoma (PTC). |
| Ethics approval(s) |
Approved 25/03/2021, Institutional Review Board of Chinese PLA General Hospital (No.28 Fuxing Road, Beijing, 100853, China; +86 (0)10-66937166; gemma-y@163.com), ref: S2019-211-02 |
| Health condition(s) or problem(s) studied | T1N0M0 papillary thyroid carcinoma |
| Intervention | A propensity score matching was used to evaluate the outcomes of radiofrequency ablation or microwave ablation for the treatment of T1N0M0 papillary thyroid carcinoma. RFA or MWA was considered only in patients with T1N0M0 PTC unsuitable for surgery or rejected surgery/active surveillance clearly. The patients underwent RFA or MWA by US physicians with over 10 years of experience in interventional thyroid US-performed ablation. The RFA or MWA was selected according to the physician’s experience and modality preference. After treatment, follow-ups were performed at 1, 3, 6, 12, and every 6-12 months thereafter. Ultrasound and contrast-enhanced ultrasound were performed at each follow-up evaluation. Chest CT was performed annually to monitor distant metastases. The study lasts 2 years in total. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Disease progression, defined as follows: 1. Cervical lymph node metastases confirmed by biopsy 2. Recurrent tumor confirmed by biopsy 3. Persistent tumor (residual tumor at the site of the ablated tumor) confirmed malignant by biopsy 4. Distant metastases confirmed by chest CT Recurrence-free survival was calculated from treatment initiation to disease progression or the last follow-up visit |
| Secondary outcome measures | 1. Volume reduction = ([initial volume-final volume] × 100)/initial volume measured using ultrasound at 1, 3, 6, 12 months, and every 6-12 months thereafter 2. Tumor complete disappearance (complete disappearance of the ablated tumor on ultrasound and contrast-enhanced ultrasound) at 1, 3, 6, 12 months, and every 6-12 months thereafter 3. Complications, recorded by the standard for image-guided thyroid ablation after RFA or MWA treatment |
| Overall study start date | 01/07/2018 |
| Completion date | 30/09/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 1111 |
| Total final enrolment | 1111 |
| Key inclusion criteria | 1. Solitary papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration 2. Tumors with a maximum diameter ≤20 mm 3. No clinical or imaging evidence of extrathyroidal extension, lymph node metastases and distant metastases on ultrasound, and neck and chest CT 4. No history of neck irradiation 5. Follow-up period ≥24 months |
| Key exclusion criteria | 1. Convincing evidence of aggressive type on biopsy 2. Multiple tumors 3. Incomplete data or lost to follow-up |
| Date of first enrolment | 01/07/2018 |
| Date of final enrolment | 30/09/2021 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
100853
China
Sponsor information
Hospital/treatment centre
No.28 Fuxing Road
Beijing
100853
China
| Phone | +86 (0)66937394 |
|---|---|
| lmsh1225@yeah.net | |
| Website | http://www.301hospital.com.cn/index.html |
"ROR" |
https://ror.org/039713658 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- PLA General Hospital
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analyses during the current study will be available upon request from Dr Lin Yan (gemma-y@163.com). The type of data that will be shared: anonymized data Dates of availability: 31/12/2025 Whether consent from participants was required and obtained: consent has been obtained. Comments on data anonymization: all data have been anonymized. |
Editorial Notes
25/10/2023: Study's existence confirmed by the Institutional Review Board of Chinese PLA General Hospital.
