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Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism

NCT ID: NCT06708871

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

520 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-26

Study Completion Date

2028-12-26

Brief Summary

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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

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Conditions

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Cure Rate Complication Rate Efficacy and Safety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Therma ablation

Thermal ablation

Intervention Type 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

Parathyroidectomy

Intervention Type PROCEDURE

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

Interventions

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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).

Intervention Type PROCEDURE

Parathyroidectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ping Liang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yang Liu

Role: CONTACT

[email protected]
+8616601565730

Other Identifiers

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S2024-546-01

Identifier Type: -

Identifier Source: org_study_id