Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism

Chinese PLA General Hospital (301 Hospital)

Status: Not yet enrolling

Conditions: Clinical Symptoms; PTH; Achievement Rate; Calcium; Efficacy and Safety

Treatments: Procedure: parathyroidectomy; Procedure: Thermal ablation

Study type: Observational

Funder types: Other

Identifiers

NCT06709586

S2024-11-10

Details and patient eligibility

About

Secondary hyperparathyroidism (SHPT), which is frequently associated with chronic kidney disease, leads to problems such as bone pain, fractures, and cardiovascular issues, thereby affecting patients' quality of life. This clinical trial is designed to compare the efficacy of thermal ablation and surgical treatment for SHPT. Parameters including parathyroid hormone levels, serum calcium and phosphorus levels, SHPT-related symptoms (for example, bone pain, muscle weakness), and complication occurrence will be monitored. The advantages involve enabling better treatment decisions for patients, enhancing patients' quality of life, and alleviating the burden on families, in addition to augmenting the clinical knowledge of healthcare providers. However, both treatments carry risks. Thermal ablation may have problems like incomplete ablation, local tissue damage, and blood parameter changes. Surgical risks comprise bleeding, infection, adjacent tissue damage (such as the recurrent laryngeal nerve), and hypoparathyroidism. The investigators will strive to minimize these risks. This trial is of great significance for SHPT treatment, and the investigators welcome participants to contribute to the advancement of medical science in this area.

Enrollment: 612 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• persistent serum iPTH (intact parathyroid hormone) levels > 800 pg/mL；
• resistance to calcimimetics, vitamin D, and its analogs, with ineffective conventional internal medicine comprehensive treatment；
• severe bone pain, osteoporosis, muscle pain, ectopic soft tissue calcification, or other factors affecting quality of life；
• imaging examinations indicating the presence of at least one enlarged parathyroid gland

Exclusion criteria

• severe bleeding tendency or coagulation disorders, severe cardiopulmonary abnormalities, and abnormal vital signs such as severe hypertension, arrhythmias, and anemia

Trial design

612 participants in 2 patient groups

Therma ablation

Treatment:

Procedure: Thermal ablation

Parathyroidectomy

Treatment:

Procedure: parathyroidectomy