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IRCT20210204050241N1 IRCT 2021-04-26 Esfahan University of Medical Sciences Comparison of the results of treatment of the primary parathyroid adenoma with surgery or ablation with ethanol. Comparative effectiveness of treating primary hyper-parathyroid patients due to parathyroid adenoma with parathyroidectomy versus ultrasonography-guided alcohol ablation 2021-05-05 anticipated 120 Complete https://irct.ir/trial/55231 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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. 3 Benign parathyroid adenoma. Intervention 1: Intervention group 1: Classic surgical resection of parathyroid adenoma with a neck incision. Intervention 2: Intervention group 2: After complete neck ultrasonography with doppler, the number, size, location, and vascularity index of adenoma will be evaluated. After preparation and draping, under local anesthesia, hydrodissection of the surrounding tissue by injecting distilled water will be performed under ultrasonography guide and the adenoma will be released from the trachea, esophagus, and recurrent laryngeal nerve. The adenoma then will be ablated with pure sterile ethanol (99.5%) until becomes avascular. 1-4 cc of ethanol will be injected each time according to the size and vascularity index of the adenoma. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Not decided yet
public Alireza Firoozfar
Surgery office, Alzahra hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3236 5742 alireza.firoozfar@resident.mui.ac.ir Esfahan University of Medical Sciences scientific Alireza Firoozfar
Surgery office, Alzahra hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3236 5742 alireza.firoozfar@resident.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with symptomatic benign parathyroid adenoma confirmed by ultrasound, MIBI scan, and fine needle aspiration no limit 50 years Both Patients with MEN1 or MEN2 syndrome Patients with suspected parathyroid malignant adenoma Patients with secondary or tertiary hyperparathyroidism Not willing to participate in the trial GFR<30 ml/min/1.72 m2 age above 50 D35.1 Benign neoplasm of parathyroid gland Treatment - Surgery Treatment - Other Intervention group 1: Classic surgical resection of parathyroid adenoma with a neck incision Intervention group 2: After complete neck ultrasonography with doppler, the number, size, location, and vascularity index of adenoma will be evaluated. After preparation and draping, under local anesthesia, hydrodissection of the surrounding tissue by injecting distilled water will be performed under ultrasonography guide and the adenoma will be released from the trachea, esophagus, and recurrent laryngeal nerve. The adenoma then will be ablated with pure sterile ethanol (99.5%) until becomes avascular. 1-4 cc of ethanol will be injected each time according to the size and vascularity index of the adenoma. Serum calcium level. Timepoint: Before the intervention, 24 hours, two weeks, three months, and six months after the intervention. Method of measurement: Blood sample tests. Serum PTH level. Timepoint: Before the intervention, 24 hours, two weeks, three months, and six months after the intervention. Method of measurement: Blood sample tests. Adenoma recurrence (reoperation or re-injection of alcohol). Timepoint: Within 3 months and 6 months after the intervention. Method of measurement: Changes in serum calcium and parathyroid hormone levels after intervention. Esfahan University of Medical Sciences Approved 2021-03-27 Ethics committee of isfahan university of medical sciences Isfahan University of Medical Sciences, Hezar Jerib blvd. Azadi Sq. isfehan Isfehan Iran (Islamic Republic of)