Clinical Trials Directory

Trials / Completed

CompletedNCT01306916

Coexisting Thyroid Disease and Hyperparathyroidism

Status
Completed
Phase
Study type
Observational
Enrollment
30 (actual)
Sponsor
Walter Reed Army Medical Center · Federal
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Timeline

Start date
2004-09-01
Primary completion
2010-12-01
Completion
2012-07-01
First posted
2011-03-02
Last updated
2012-07-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01306916. Inclusion in this directory is not an endorsement.