Condition or disease | Intervention/treatment | Phase |
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Papillary Thyroid Microcarcinoma | Procedure: Radiofrequency Ablation Procedure: Conventional Surgery | Not Applicable |
The incidence of thyroid carcinoma, especially the papillary thyroid microcarcinoma (PTMC), has increasingly rapidly, due to the development of technologies of diagnosis, during the past 20 years. PTMC defined by the World Health Organization (WTO) as the largest dimension less than 1 cm. Previous autopsy study demonstrated that the lesions are normal in many people and accompany them latently until they die because of another reasons. The long-term outcome of PTMC is good and, as expected, more than 90% PTMC aren't progress for many years.
Ultrasound-guided Radiofrequency Ablation (RFA) treatment was introduced to clinical practice few years ago. According to the 2015 American Thyroid Association (ATA) guideline, the treatment of radiofrequency and laser ablation are mentioned to be used in recurrent thyroid cancer. But clinical practice shows that the RFA treatment for low risk PTMC braces well effect,low financial budget,high safety and even rare postoperative complication.
Although the cohort study was performed before, the real answer concerning about whether RFA is a rational choice for treating PTMC lacks more powerful evidences. The investigator considers to perform a randomized, controlled and multicenter study as a high-quality evidence and demonstrated the effect of PRF in low risk PTMC treatment.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter, Randomized and Controlled Trial of Radiofrequency Ablation vs. Conventional Surgery as Treatment of Papillary Thyroid Microcarcinoma (PTMC) |
Actual Study Start Date : | June 1, 2019 |
Estimated Primary Completion Date : | February 1, 2024 |
Estimated Study Completion Date : | February 1, 2024 |
Arm | Intervention/treatment |
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Experimental: Radiofrequency Ablation
Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) procedure.
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Procedure: Radiofrequency Ablation
Patients were supine with the neck exposure completely during the procedure. Local anesthesia with 1% lidocaine was injected at the subcutaneous puncture site and the thyroid anterior capsule. If the distance between the tumor and critical cervical structures was less than 5 mm, normal saline was injected to form at least 1 cm distance between the tumor and the critical structure to prevent the unwilling thermal injury. RFA was performed using the moving-shot technique and RFA power was 5 W, if a transient hyperechoic zone did not form at the electrode tip within 5-10 seconds. The RFA extent exceeded the tumor edge to prevent marginal residue and recurrence. The ablation was terminated when all portions of the target ablation area had changed to hyperechoic zones.
Other Name: RFA
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Active Comparator: Conventional Surgery
Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy procedure.
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Procedure: Conventional Surgery
Patient is performed total thyroidectomy or thyroid lobectomy depending on the intraoperative situation, disease condition and comprehensive judge by surgeon. Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat and placenta muscle are incised and separated successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process.
Other Name: Total thyroidectomy/Thyroid lobectomy
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measured by satisfaction questionnaire designed by investigator group: items:
1.Are you satisfied with surgery? 2.Are you satisfied with the RFA procedure? scale range from 1 to 10; by the increasing of scale, the outcome is defined as good.
scale range from 1 to 4 For the question 5,9,13,17,18, the outcome is define as good by the increasing of scale.
For the others, the outcome is defined as bad by the increasting of scale.(scale 1=No or very few, scale2=sometimes, scale3=often, scale4=always)
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pintong Huang, director | +8618857168333 | huangpintong@126.com | |
Contact: jifan Chen, collegue | +8613605771565 | chenjifan0619@163.com |
China, Tianjin | |
General Surgery Department, Tianjin Medical University General Hospital | Recruiting |
Tianjin, Tianjin, China, 022 | |
Contact: Jie Zhang, director +8615822798742 wzq_bf@163.com | |
Contact: Ruoyu Jiang, collegue +8618622632394 jiangruoyu000@aliyun.com | |
China, Zhejiang | |
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting |
Hangzhou, Zhejiang, China, 0571 | |
Contact: Pintong Huang, director +8618857168333 huangpintong@126.com | |
Contact: Jifan Chen, collegue +8613605771565 chenjifan0619@163.com | |
Ukraine | |
Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine" | Not yet recruiting |
Kharkiv, Ukraine, 61024 | |
Contact: Sviatoslav Balaka +380509356958 balaka.svjat@gmail.com | |
Contact: Hennadii Hrechikhin +380509188586 interv.oncology@gmail.com |
Principal Investigator: | Pintong Huang, director | Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 13, 2019 | ||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||
Last Update Posted Date | December 19, 2020 | ||||||||
Actual Study Start Date ICMJE | June 1, 2019 | ||||||||
Estimated Primary Completion Date | February 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Recurrent-free Survival Rate [ Time Frame: 5 years ] record detecting recurrence of PTMC post-surgery or post-FRA
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma. | ||||||||
Official Title ICMJE | A Multicenter, Randomized and Controlled Trial of Radiofrequency Ablation vs. Conventional Surgery as Treatment of Papillary Thyroid Microcarcinoma (PTMC) | ||||||||
Brief Summary | The treatment of Papillary Thyroid Microcarcinoma (PTMC) nowadays varies among physicians, surgeons and radiologist. The recently published articles show that the prognosis of PTMC by different means of treatment strategies tends to be good. But multicentered, randomized, parallel and prospective study is rare. RFA is the abbreviation of "Radiofrequency Ablation", which tends to be an alternative strategy except conventional surgery. The investigator aims to confirm whether RFA for treating PTMC braces same effectiveness and prognosis comparing with conventional surgery. Besides, this trial also investigates the safety, economy and psychological quality under different treatments. | ||||||||
Detailed Description |
The incidence of thyroid carcinoma, especially the papillary thyroid microcarcinoma (PTMC), has increasingly rapidly, due to the development of technologies of diagnosis, during the past 20 years. PTMC defined by the World Health Organization (WTO) as the largest dimension less than 1 cm. Previous autopsy study demonstrated that the lesions are normal in many people and accompany them latently until they die because of another reasons. The long-term outcome of PTMC is good and, as expected, more than 90% PTMC aren't progress for many years. Ultrasound-guided Radiofrequency Ablation (RFA) treatment was introduced to clinical practice few years ago. According to the 2015 American Thyroid Association (ATA) guideline, the treatment of radiofrequency and laser ablation are mentioned to be used in recurrent thyroid cancer. But clinical practice shows that the RFA treatment for low risk PTMC braces well effect,low financial budget,high safety and even rare postoperative complication. Although the cohort study was performed before, the real answer concerning about whether RFA is a rational choice for treating PTMC lacks more powerful evidences. The investigator considers to perform a randomized, controlled and multicenter study as a high-quality evidence and demonstrated the effect of PRF in low risk PTMC treatment. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Papillary Thyroid Microcarcinoma | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
200 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | February 1, 2024 | ||||||||
Estimated Primary Completion Date | February 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China, Ukraine | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03808779 | ||||||||
Other Study ID Numbers ICMJE | 2013-004-A012 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | huang pintong, Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
Study Sponsor ICMJE | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |