Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism

Not yet recruiting

• Conditions: Cure Rate; Complication Rate; Efficacy and Safety

• Registration Number: NCT06708871
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-11-10
• Study Start: 2024-11-26
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2028-11-26
• Study Completion: 2028-12-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 520

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cure rate	6 months after surgery or ablation	The cure rate is the probability that postoperative levels of parathyroid hormone (PTH) and blood calcium reach the target values.

Secondary Outcome Measures

Name	Time	Method
complication rate	within 30 days after surgery or ablation	The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period.
symptom remission rate	1 year after treatment initiation	The symptom remission rate refers to the proportion of the number of patients whose symptoms have been alleviated to the total number of patients treated in the treatment of primary hyperparathyroidism, either by surgery or ablation.
Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery	6 months post-treatment	The probability of normal serum calcium and serum phosphorus levels after ablation or surgical treatment for primary hyperparathyroidism is defined as the proportion of patients in whom the levels of blood calcium and blood phosphorus return to the normal physiological range among all the patients who have received either ablation or surgical procedures for this condition.
Bone mineral density change	2 years	Bone mineral density change after treatment is defined as the alteration in bone density measured by DEXA in patients with primary hyperparathyroidism after surgery or ablation.