A Multicenter Trial of Radiofrequency Ablation vs. Surgery as Treatment of Papillary Thyroid Microcarcinoma.
NCT ID: NCT03808779
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2019-06-01
2024-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiofrequency Ablation
Eligible participants with PTMC will be randomly assigned to this group and undergo radiofrequency ablation(RFA) 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.
Conventional Surgery
Eligible participants with PTMC will be randomly assigned to this group and undergo total/thyroid lobectomy 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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>=18 years old
* Bethesda Category V or VI
* Single nodule without thyroid capsule contact
* Nodule has more than 3mm distance far from recurrent laryngeal nerve, carotid artery and trachea.
* No clinical evidences show there is local or distant metastasis.
* Without chemotherapy, radiotherapy and other related therapies.
* Patients and their family member totally understand and sign the informed consent.
Exclusion Criteria
* Combined with other types of thyroid cancer or hyperthyroidism.
* Contralateral vocal cord paralysis
* With local or distant metastasis
* Pregnant woman
* With radiation exposure history
18 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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huang pintong
Director of Department of Ultrasound, Professor of Zhejiang University School of Medicine
Principal Investigators
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Pintong Huang, director
Role: PRINCIPAL_INVESTIGATOR
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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General Surgery Department, Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Department of Ultrasound, Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Interventional Oncology Centre, State Institution "Grigoriev Intstitute for Medical Radiology NAMS of Ukraine"
Kharkiv, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Jie Zhang, director
Role: primary
Ruoyu Jiang, collegue
Role: backup
Pintong Huang, director
Role: primary
Jifan Chen, collegue
Role: backup
Sviatoslav Balaka
Role: primary
Hennadii Hrechikhin
Role: backup
Other Identifiers
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2013-004-A012
Identifier Type: -
Identifier Source: org_study_id