Comparative effectiveness of treating primary hyper-parathyroid patients due to parathyroid adenoma with parathyroidectomy versus ultrasonography-guided alcohol ablation

Comparison of treating primary hyperparathyroidism due to parathyroid adenoma with alcohol ablation under ultrasound guide compared with surgical resection of adenoma.

Randomized none-blinded parallel clinical trial

Patients who refer to medical centers with suspected signs and symptoms of hypercalcemia and hyperparathyroidism, after evaluating their inclusion and non-inclusion criteria and obtaining informed consent and knowledge of both treatments and equal probability of being in each group. Due to ethical issues, no blinding will occur. Still, the order of placement in each analysis group will be determined, and the details of this will be hidden from researchers until the end of the project. An interventional radiologist ablates one group of patients' adenoma under the guidance of ultrasound with alcohol. After the operation, the serum levels of calcium and parathyroid hormone are regularly evaluated, and an experienced surgeon resects the other group. It is evaluated in the same way after the operation.

Patients with symptomatic benign parathyroid adenoma confirmed by ultrasound, systemic scan, and fine-needle aspiration who wish to participate in the study and who do not suspect MEN2 or MEN1 syndrome, malignancy, secondary or tertiary hyperparathyroidism will be selected for the study.

Patients who meet the admission criteria and do not meet the exclusion criteria will be randomly divided into two groups: alcohol injection into the adenoma under the guidance of an ultrasond by an experienced radiologist or adenoma resection surgery by an experienced surgeon.

Comparison between groups and intragroup mean and changes in corrected serum calcium and parathyroid hormone levels after each treatment intervention.

The patients are allocated into either the intervention or control group using a non-stratified block randomization method to keep an even randomization ratio of (1:1). Random Allocation Software is used by our expert analytics to determine the list and group of patients. He is blinded to the selection process and pre-and post-operative assessments. The block size will be equal and is set to 4, the sufficient and estimated sample size will be 120, then the allocation code is set to sequential. The analytics will use the output of software to determine the sequence and allocation of patients. Then each code is written on a non-transparent envelope and a paper is put in it in which the "Surgery" or "Alcohol" is written on the paper. The series of the envelope will be according to the software's list and they will keep in a large box with a locker. The analytics has the key for the box and this box will be kept in his room which the analytics has its only key and has no windows. As the patients enrolled in the study sequentially, the analytics use the designated envelope. The mechanism of randomization and block size will not be revealed to the principal investigator and other involved physicians until the end of the trial.