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Not yet recruiting NCT06708871

Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism

— Observational Cure Rate Complication Rate Efficacy and Safety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Thermal ablation, Parathyroidectomy.
Who it may be relevant to
Registry conditions: Cure Rate, Complication Rate, Efficacy and Safety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism: a Multicenter Study

Overview

This study is a prospective, multicenter study designed to compare the efficacy and safety of surgical treatment versus ablation therapy (including radiofrequency ablation and microwave ablation) for patients with primary hyperparathyroidism (PHPT). The study will assess the impact of both treatment modalities on serum parathyroid hormone (iPTH) and calcium levels, clinical symptom improvement, bone mineral density enhancement, reduction in the incidence of urinary system stones, and postoperative complication rates. While surgical treatment has been the standard of care for PHPT, offering definitive cure, it carries inherent surgical risks and complications. Ablation therapy, as a minimally invasive approach, presents a novel alternative with reduced trauma and fewer complications. The outcomes of this study will inform clinical decision-making and potentially optimize treatment strategies for patients with PHPT.

Interventions

  • Procedure Thermal ablation
    Thermal ablation is a minimally invasive procedure used to treat primary hyperparathyroidism, a condition where one or more of the parathyroid glands produce excessive amounts of parathyroid hormone (PTH). The treatment involves using heat to destroy the overactive parathyroid tissue. This can be done through various methods such as radiofrequency ablation (RFA) and microwave ablation(MWA).
  • Procedure Parathyroidectomy
    Parathyroidectomy is a surgical procedure to remove one or more of the parathyroid glands in cases of hyperparathyroidism.

Primary outcome measures

  • cure rate [Time frame: 6 months after surgery or ablation]
Secondary outcome measures (4)
  • complication rate [Time frame: within 30 days after surgery or ablation]
  • symptom remission rate [Time frame: 1 year after treatment initiation]
  • Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery [Time frame: 6 months post-treatment]
  • Bone mineral density change [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Symptomatic patients with primary hyperparathyroidism, such as those with symptoms in any system including the kidneys, bones, gastrointestinal tract, psychoneurological system, or those with atypical symptoms such as muscle weakness, dysfunction, and sleep disorders.
  • Asymptomatic PHPT patients with any of the following conditions:

① Serum calcium is higher than the upper limit of the normal value by 1 mg/dL (0.25 mmol/L);

② There is objective evidence of renal involvement, including asymptomatic kidney stones, nephrocalcinosis, hypercalciuria (24 - hour urinary calcium level > 400 mg/dL) on renal imaging, or impaired renal function (glomerular filtration rate < 60 mL/min);

③ There is evidence of osteoporosis (bone mineral density decreased by 2.5 standard deviations at any site) and/or radiographic evidence of fragility fractures.

④ Age < 50 years

⑤ The patient cannot accept routine follow - up observation.

  • Imaging examination shows that at least one parathyroid gland is enlarged.

Exclusion criteria

  • diagnosis of secondary or tertiary HPT
  • severe coagulation disorder
  • severe cardiopulmonary insufficiency

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06708871 · S2024-546-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗