Thermal Ablation Versus Parathyroidectomy for Secondary Hyperparathyroidism

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• Hyperparathyroidism 306
• Hyperparathyroidism, Secondary 185

Study population

Groups and cohorts

• Therma ablation

  Procedure: Thermal ablation

• Parathyroidectomy

  Procedure: parathyroidectomy

Interventions

• ProcedureThermal ablation

  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.

• Procedureparathyroidectomy

  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.

Primary outcomes

1. Achievement rate of target PTH value

   Time frame: 6 months after surgery or ablation

2. 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

Secondary 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 ablation

2. 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-treatment

3. 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 years

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

   Changes in Bone Metabolism Markers will be evaluated by measuring specific biochemical parameters. These include serum levels of bone-specific alkaline phosphatase (BALP), which is a biomarker reflecting osteoblast activity. Another important marker is N-terminal propeptide of type I collagen (PINP), which is involved in collagen synthesis and provides insights into bone formation. ALP is a well-known enzyme related to bone metabolism and its elevation can be indicative of increased osteoblastic activity. The levels of these markers will be determined using enzyme-linked immunosorbent assay (ELISA) kits, which are highly sensitive and specific laboratory assays.

   Time frame: 1 year

5. All - cause mortality rate

   Time frame: 2 years

Other 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-procedure

2. Readmission Rate within 30 Days

   Time frame: within 30 days after surgery or ablation

3. 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 year

Individual participant data

Plan to share: No