Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism

NCT06709586 | Not Yet Recruiting

• 1 other identifier: S2024-11-10
• Study Type: observational
• Target: 612
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Achievement rate of target PTH value

  6 months after surgery or ablation

• 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.

  1 year after treatment

Secondary Outcomes (5)

• complication rate

  within 30 days after surgery or ablation

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

  6 months post-treatment

• Bone mineral density change

  2 years

• Assessment of Changes in Bone Metabolism Markers Including BALP, PINP, and ALP for Treating Primary Hyperparathyroidism by Surgery and Ablation

  1 year

• All - cause mortality rate

  2 years

Other Outcomes (3)

• 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

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

  through study completion, an average of 2 year

Study Arms (2)

Therma ablation

Procedure: Thermal ablation

Parathyroidectomy

Procedure: parathyroidectomy

Interventions

Thermal ablation PROCEDURE

Thermal ablation is a treatment for secondary hyperparathyroidism. There are radiofrequency ablation (RFA) and microwave ablation (MWA). For RFA, an electrode needle is inserted into the parathyroid under imaging guidance. High - frequency current heats the tissue to cause necrosis. MWA uses electromagnetic waves to generate heat by friction. Before ablation, imaging and lab tests are done for evaluation. During the process, precise positioning and real - time monitoring are key. After that, patients are observed for bleeding, swelling and other symptoms, and tests are repeated to assess the effect.

Therma ablation

parathyroidectomy PROCEDURE

Parathyroidectomy for secondary hyperparathyroidism is a common approach. The surgeon first makes an incision in the neck area under general or local anesthesia. Then, the enlarged parathyroid glands are carefully identified and dissected. Precise surgical skills are required to avoid damaging nearby structures such as the recurrent laryngeal nerve and blood vessels. After the removal of the abnormal parathyroid tissue, the wound is closed.

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 secondary hyperparathyroidism based on clinical symptoms (such as bone pain, fractures, pruritus), biochemical parameters (elevated parathyroid hormone, abnormal calcium, phosphorus, and alkaline phosphatase levels), and relevant medical history (especially those with underlying chronic kidney disease or other relevant disorders). All patients must provide written informed consent after a detailed discussion of the study purpose, procedures, potential risks, and benefits of both treatment options by the research team.

You may qualify if:

• 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

You may not qualify if:

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

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 29, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): November 26, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: November 29, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share