Ultrasound Guided Fine Needle Aspiration of Parathyroid Gland as a Pre Operative Localization Tool to Identify Pathological Parathyroid
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- parathyroid hormone level from a pathological parathyroid gland
研究概览
简要总结
Identification and localization of pathological parathyroid gland before parathyroidectomy is traditionally done by a combination of two methods: ultrasound and sestamibi scan. The investigators would like to show that one exam that includes ultrasound and fine needle aspiration of the parathyroid gland for parathyroid hormone level is as accurate as the traditional method.
详细描述
A prospective, open label, single arm trial that includes participants that suffer hypercalcemia due to primary hyperparathyroidism and are candidates for parathyroidectomy.
participants visit the investigator's head and neck clinic. the investigator confirms that the participant has an indication for parathyroidectomy according to the official criteria. Later on, the investigator looks at the localization tests that have already been done (neck ultrasound and MIBI [methoxyisobutyllisonitrile] scan) in order to plan the surgery. In case participant has not made those tests- the investigator fills a written request to do so. then, the investigator will perform a neck ultrasound and identifies the pathological parathyroid gland. The suspected pathological gland is aspirated using a 27 gauge needle attached to a 5 cc syringe fills with 1 cc saline (0.9% NaCL) under the guidance of the ultrasound. The aspirated material is sent for 2 examinations:
- parathyroid hormone level: the aspirated material is injected into a ethylenediaminetetraacetic acid (EDTA) vial and send to the hospital's endocrine laboratory. the parathyroid hormone level is processed using chemiluminescence method and represented in Pg/ml units.
- cytology examination. The aspirated material is spread on a glassed slide and prepared with a Giemsa stain for a cytologic examination. cytologic features such as cell type, cytoplasmic characteristics,cell block structure and chromatin appearance is addressed by the pathologist.
After completion of the ultrasound - guided needle aspiration the participant is given an exact date for the surgery.
The surgery is carried out routinely with the same surgical steps that the investigator is familiar with. At the end of surgery, after the pathological parathyroid gland was extracted from the neck, it is aspirated with a 27Gy needle attached to a 5 cc, syringe filled with a 1 cc saline (0.9% NaCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •above 18 years old
- •participants that suffer from primary hyperparathyroidism with an indication for parathyroidectomy
排除标准
- •Chronic renal failure
- •kidney transplant participant
- •MEN (multiple endocrine neoplasia) syndrome
- •pregnancy
结局指标
主要结局
parathyroid hormone level from a pathological parathyroid gland
时间窗: one month after the patient starts the study
Under ultrasound guidance, the investigators will locate a neck leison which based on previous localization imaging modalities, is proven to be a pathological parathyroid gland.The investigators will aspirate material from this gland and send it for measurement of parathyroid hormone level. we will prove that a lesion that contains high levels of parathyroid hormone is indeed a parathyroid gland. thereby, this method may replace other localization methods
次要结局
- parathyroid gland cytology(one month after the patient starts the study)
- parathyroid gland cytology from a pathological parathyroid gland.(one month after the patient starts the study)
研究者
Paker Miki
Dr.paker miki. principal investigator
HaEmek Medical Center, Israel