Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Imaging examination shows that at least one parathyroid gland is enlarged.
Disqualifiers
diagnosis of secondary or tertiary HPT
severe coagulation disorder
severe cardiopulmonary insufficiency
Trial population
Patients must have a confirmed diagnosis of PHPT based on biochemical and clinical evaluations. Biochemical evidence includes elevated parathyroid hormone (PTH) levels in conjunction with hypercalcemia (serum calcium above the normal reference range). Clinical manifestations may include, but are not limited to, bone pain, osteoporosis, kidney stones, or other symptoms related to the disease.All patients must provide written informed consent after a detailed discussion of the study procedures, potential risks, and benefits of both thermal ablation and surgical treatment options. This ensures that patients are fully aware of what participation in the study entails and have voluntarily agreed to take part.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Thermal ablation
Procedure/SurgeryThermal 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/SurgeryParathyroidectomy is a surgical procedure to remove one or more of the parathyroid glands in cases of hyperparathyroidism.
Treatment groups
520 Participants
are divided into 2 treatment groupsGroup A: Therma ablation1 intervention
Group B: Parathyroidectomy1 intervention
Trial outcomes
Primary outcomes
1
cure rate
The cure rate is the probability that postoperative levels of parathyroid hormone (PTH) and blood calcium reach the target values.
Time frame
6 months after surgery or ablationSecondary outcomes
1
complication rate
The incidence rate of complications refers to the proportion of patients who experience complications after a surgical procedure within a certain period.
Time frame
within 30 days after surgery or ablation2
symptom remission rate
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.
Time frame
1 year after treatment initiation3
Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery
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.
Time frame
6 months post-treatment4
Bone mineral density change
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.
Time frame
2 yearsOther outcomes
1
Cosmetology Scoring（Scar Cosmesis Assessment and Rating Scale）
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.
Time frame
at 3 months, 6 months, and 1 year post-procedure2
Readmission Rate within 30 Days
Time frame
within 30 days after surgery or ablation3
All - cause mortality rate
Time frame
2 years4
Evaluation of the Learning Curve for Surgical and Ablation Procedures in Treating Primary Hyperparathyroidism: Incorporating Key Performance Indicators and Patient Cure Outcomes
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.
Time frame
through study completion, an average of 2 yearLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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