Clinical Trial: Coexisting Thyroid Disease and Hyperparathyroidism

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Coexisting Thyroid Disease and Hyperparathyroidism

Brief Summary:

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).

Detailed Summary:
Sponsor: Walter Reed Army Medical Center

Current Primary Outcome: To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism. [ Time Frame: One year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism. [ Time Frame: One year ]

Original Secondary Outcome: Same as current

Information By: Walter Reed Army Medical Center

Dates:
Date Received: January 12, 2011
Date Started: September 2004
Date Completion:
Last Updated: July 2, 2012
Last Verified: July 2012