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Coexisting Thyroid Disease and Hyperparathyroidism

Sponsor
Walter Reed Army Medical Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01306916
Collaborator
(none)
30
Enrollment
1
Location
94
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Coexisting Thyroid Disease and Hyperparathyroidism
    Study Start Date :
    Sep 1, 2004
    Actual Primary Completion Date :
    Dec 1, 2010
    Actual Study Completion Date :
    Jul 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    Group 1 of 1

    diagnosis of primary and secondary hyperparathyroidism scheduled to undergo parathyroid resection.

    Outcome Measures

    Primary Outcome Measures

    1. To determine the prevalence and specific type of thyroid disease in patients with hyperparathyroidism. [One year]

    Secondary Outcome Measures

    1. To determine the frequency with which the presence of thyroid disease alters the treatment plan for patients with hyperparathyroidism. [One year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    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.

    Exclusion Criteria:

    • Patients who have previously undergone thyroid or parathyroid operation

    • Patients with medullary thyroid carcinoma and hyperparathyroidism or suspected multiple endocrine neoplasm syndrome

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walter Reed Army Medical Center Washington District of Columbia United States 20307

    Sponsors and Collaborators

    • Walter Reed Army Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alexander Stojadinovic, Director, Combat Wound Initiative Program, Walter Reed National Military Medical Center
    ClinicalTrials.gov Identifier:
    NCT01306916
    Other Study ID Numbers:
    • 04-20018
    First Posted:
    Mar 2, 2011
    Last Update Posted:
    Jul 3, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Alexander Stojadinovic, Director, Combat Wound Initiative Program, Walter Reed National Military Medical Center
    thyroid disease, hyperthyroidism
    Additional relevant MeSH terms:
    Thyroid Diseases
    Hyperparathyroidism
    Hyperthyroidism

    Study Results

    No Results Posted as of Jul 3, 2012