KCT0007793尚未招募未知
Radiofrequency ablation for Patients with hyperparathyroidism using Medical Electrocautery Apparatus: Multicenter, Non-randomized, Open, Single-Arm, Investigator Initiated Trial for Exploratory Evaluation of Safety and Efficacy
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 100(Year)（—）
- 性别
- All
入选标准
- •(1) A person who is an adult subject over the age of 19 and does not fall under the exclusion criteria
- •(2) Patients who need surgical treatment for parathyroidism (primary, secondary, and tertiary) meet one or more of the following criteria
- •I) Patients who refuse surgical treatment due to concerns about postoperative scars, side effects, and general anesthesia
- •II) Patients at high risk of surgical treatment: cardiovascular disease, brain disease, lung disease, and other organs that do not respond well to medication, including cancer and other severe medical conditions. However, if you are a kidney failure patient and do not meet the exclusion criteria, you will be included in the treatment.
- •III) Patients who recurred after surgical treatment
- •*Definition of patients requiring surgical treatment
- •? If symptoms are present in the case of primary parathyroid hyperthyroidism, or if one of the following conditions is satisfied in the case of asymptomatic
- •1. Under 50
- •2. If serum calcium exceeds the normal upper limit of 1 mg/dL, osteoporosis is diagnosed by bone density test or spinal fracture is confirmed
- •3. When the creatinine excretion rate has decreased to less than 60 mL/min
- •4. In case of urinary tract stones or neolithography
- •5. When hypercalcemia (>400 mg/day) is accompanied
- •? Secondary/trivial hyperthyroidism patients who did not respond to medical treatment)
- •(3) One or more parathyroid lesions that are localized to the same area as ultrasound in one of the choline PET/CT, CT parathyroid, and parathyroid scans are clearly identified
- •(4) A person deemed technically capable of high-frequency ablation
- •(5) A person who voluntarily agrees to the clinical trial and is able to visit for the next observation
排除标准
- •(1)People with a tendency to bleed from blood tests such as CBC, PT, and aPTT.TT
- •(Prothrombin time > 14 seconds, activated partial thromboplastin time > 40 sec, or platelet count < 150 x 103/µL)
- •However, even if the blood test is within the normal range, careful consideration is recommended if the risk of bleeding is high in the past, or if anti-thrombotic drugs have been taken for cardiovascular disease or other reasons
- •(2) Patients who are not expected to be followed up after high frequency resection
- •(3) Pregnant women or subjects under 19 years of age, mental illness
- •(4) a person using an artificial pacemaker
- •(5) clinically suspected parathyroid cancer
- •(6) Patients with diseases or conditions that may affect metabolism and levels of calcium or phosphorus in addition to parathyroidism (long-term lithium patients such as bipolar disorder, severe vitamin D-deficiency, etc.)
- •(7) Careful consideration in the case of surgery for thyroid cancer and damage to the opposite side of the laryngeal nerve. Other than that, it is not excluded just because there is a disease, trauma, or surgical history in the neck or head.
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