Thermal Ablation Versus Parathyroidectomy for Primary Hyperparathyroidism

NCT06708871 | Not Yet Recruiting

• 1 other identifier: S2024-546-01
• Study Type: observational
• Target: 520
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cure Rate; Complication Rate; Efficacy and Safety

Outcome Measures

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.

  6 months after surgery or ablation

Secondary Outcomes (4)

• complication rate

  within 30 days after surgery or ablation

• symptom remission rate

  1 year after treatment initiation

• Normalization Probability of Serum Calcium and Phosphorus after Ablation or Surgery

  6 months post-treatment

• Bone mineral density change

  2 years

Other Outcomes (4)

• Cosmetology Scoring（Scar Cosmesis Assessment and Rating Scale）

  at 3 months, 6 months, and 1 year post-procedure

• Readmission Rate within 30 Days

  within 30 days after surgery or ablation

• All - cause mortality rate

  2 years

Study Arms (2)

Therma ablation

Procedure: Thermal ablation

Parathyroidectomy

Procedure: Parathyroidectomy

Interventions

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).

Therma ablation

Parathyroidectomy PROCEDURE

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

Parathyroidectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

MeSH Terms

Interventions

Transurethral Resection of Prostate; Parathyroidectomy

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative; Endocrine Surgical Procedures

Central Study Contacts

Yang Liu

CONTACT

+8616601565730; yang2818025107@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2024
• First Posted: November 27, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): November 26, 2028
• Study Completion (Estimated): December 26, 2028
• Last Updated: November 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share