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临床试验/NCT01306916
NCT01306916已完成不适用

Coexisting Thyroid Disease and Hyperparathyroidism

Walter Reed Army Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism.

研究概览

简要总结

Purpose: Prospective studies of patients with hyperparathyroidism are warranted to determine the prevalence of concurrent thyroid disease applying the current standard of pre-operative radioscintigraphic and sonographic imaging of the neck. Timely diagnosis and treatment of co-existing thyroid disease is advantageous given the well-established increased morbidity associated with a second neck exploration. The purpose of this study is to determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism, and to determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism.

Research Design: This will be a prospective single arm observational study of up to 200 military health care beneficiaries over the age of 18 years with primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection.

Methodology: Patients will undergo standard pre-operative imaging of the neck including ultrasonography and 99mTc-sestamibi scintigraphy. An operative plan will be developed based on the information obtained from history, physical examination, laboratory studies, and imaging studies. The number and type of thyroid disease in these patients will be determined based on these non-invasive studies (Objective A). A change in the otherwise standard treatment will include those patients having partial or complete resections of their thyroid glands because: a) the patients would have undergone minimally invasive surgery if not for the results of the imaging studies, and, b) the patients who would have undergone 3 ½ gland parathyroidectomy if not for the results of the imaging studies (Objective B).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with hyperparathyroidism and appropriate indications for operation
  • Patients over 18 years of age and capable of providing informed consent
  • Each patient must provide written informed consent prior to entering the study.

排除标准

  • Patients who have previously undergone thyroid or parathyroid operation
  • Patients with medullary thyroid carcinoma and hyperparathyroidism or suspected multiple endocrine neoplasm syndrome

结局指标

主要结局

To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism.

时间窗: One year

次要结局

  • To determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism.(One year)

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Alexander Stojadinovic

Director, Combat Wound Initiative Program

Walter Reed National Military Medical Center

研究点 (1)

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