Clinical trial · Interventional
Radiofrequency Ablation Versus Hemithyroidectomy for Small Thyroid Cancers
Multi-center, 1:1 Randomized, Stratified, Parallel-group, Non-inferiority Clinical Trial of Small Thyroid Cancers Treated With Hemithyroidectomy or Radiofrequency Ablation.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
This is a multicenter randomized controlled trial including patients with small (\<2 cm) suspected or confirmed thyroid cancers. Patients are included after informed consent and randomized to one of two treatments. One treatment is a standard henithyroidectomy and the second treatment is radiofrequency ablation (RFA) of the specific tumor. The investigators will evaluate initial outcome of the allocated treatment, thyroid hormonal function, oncologic safety, quality of life, and treatment costs in a follow-up period of five years after treatment. The overall aim of the study is to improve patient's health by reducing the number of operations on small thyroid cancers. In patients with these small tumors, the long-term adverse outcome may be higher than possible benefits from the operation. For participants undergoing surgical treatment with HT, the investigators will measure final histology and both beneficial and adverse outcome from the operation. For participants undergoing RFA, the investigators expect to reduce the need for thyroid hormonal substitutions, reduce the surgical adverse outcomes, reduce treatment costs and increase QoL without a reduction in oncologic safety and outcome.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency ablation alone | Procedure | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Surgery of thyroid cancer
- interventionNames
- Procedure: Surgery
- type
- EXPERIMENTAL
- label
- RFA of thyroid cancer
- interventionNames
- Procedure: Radiofrequency ablation alone
Primary outcomes (1)
- measure
- Uncomplicated initial treatment (yes/no)
- timeFrame
- One month after randomization.
- description
- Uncomplicated treatment is defined as a composite endpoint (dichotomous; yes/no) with none of the following adverse outcomes within the first month after treatment/surgery: 1. short or long-term affection of the recurrent laryngeal nerve (RLN) based on laryngoscopy, 2. infection with a need for surgical treatment, 3. capsule rupture or bleeding with a need for operation, 4. prolonged hospital stay (more than one night), 5. any other reason for a secondary surgical intervention on the neck.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Single tumor in the thyroid gland with a FNAB suspecious of cancer or diagnostic of cancer (category V or VI in the Bethesda system) * tumor size of less than 2 cm in all dimensions. Exclusion Criteria: * suspicion of disseminated disease because of PET-positive lymph nodes ; suspect lymph-nodes by ultrasonography (US); or signs of capsular invasion of the tumor OR * tumor not eligible for RFA treatment because of high-risk location; previous thyroid surgery; concomitant hyperparathyroidism (ionized calcium \> 1.32 mmol/L and PTH \> 6 pmol//L ) OR * if the patient is pregnant OR * If the patient is unable to give informed consent.
References
Publications (0)
Data not yet available