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NCT Number: NCT06708871

Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism

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.

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Key information

Conditions

Cure Rate Complication Rate Efficacy and Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermal ablation

Procedure

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).

Parathyroidectomy

Procedure

Parathyroidectomy is a surgical procedure to remove one or more of the parathyroid glands in cases of hyperparathyroidism.

Primary outcomes

  1. cure rate

    Time frame: 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 outcomes

  1. complication rate

    Time frame: 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.

  2. symptom remission rate

    Time frame: 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.

  3. Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery

    Time frame: 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.

  4. Bone mineral density change

    Time frame: 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.

Other outcomes

  1. Cosmetology Scoring（Scar Cosmesis Assessment and Rating Scale）

    Time frame: at 3 months, 6 months, and 1 year post-procedure

    The Scar Cosmesis Assessment and Rating Scale (SCAR) will be utilized to evaluate the cosmetic outcome following surgical or ablation treatment for primary hyperparathyroidism. The observer part of the SCAR assesses six aspects: scar spread, erythema, pigmentation abnormality, surgical marks or suture tracks, hypertrophy/atrophy, and overall impression. The patient part includes two simple questions about patient satisfaction with the scar and the degree of itching. The scale has a minimum value of 0, representing the least severe scar with the best cosmetic appearance, and a maximum value of 15, signifying the most severe scar with the poorest cosmetic result. Higher scores on this scale indicate a worse cosmetic outcome.

  2. Readmission Rate within 30 Days

    Time frame: within 30 days after surgery or ablation

  3. All - cause mortality rate

    Time frame: 2 years

  4. Evaluation of the Learning Curve for Surgical and Ablation Procedures in Treating Primary Hyperparathyroidism: Incorporating Key Performance Indicators and Patient Cure Outcomes

    Time frame: through study completion, an average of 2 year

    The learning curve for surgical or ablation procedures will be evaluated by tracking and analyzing key performance indicators, with patient cure outcomes also taken into account. These indicators encompass the time taken from the start of the procedure until its completion (operation time). Additionally, the rate of occurrence of immediate and short-term post-operative complications (like bleeding, nerve injury) is considered. Patient cure status, such as complete remission of related symptoms, normalization of relevant physiological indicators, and long-term disease-free survival, will be meticulously assessed to comprehensively evaluate the effectiveness and learning the effectiveness and learning curve of these procedures.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Liu

CONTACT

[email protected]

+8616601565730

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism: a Multicenter Study

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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