Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism
Primary Purpose
Hyperparathyroidism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Minimally invasive radioguided parathyroidectomy
Sponsored by
About this trial
This is an interventional treatment trial for Hyperparathyroidism focused on measuring Radionuclide imaging, Surgery
Eligibility Criteria
Inclusion Criteria: Elevated serum calcium concentration on at least 2 occasions; if the value is <11.0 mg/dL, it must have been present for at least 6 months; if the serum albumin concentration is not normal, the ionized calcium level will be measured and must be elevated. Nephrolithiasis or documented bone mineral density less than 2.5 Standard Deviations below age matched means. Elevated or non-suppressed serum intact parathyroid hormone level
Sites / Locations
- Univ. of Michigan Hosp, Dept. of Surgery
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006329
First Posted
October 4, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00006329
Brief Title
Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2001
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
Brief Summary
Parathyroid glands are small endocrine glands that secrete a hormone which controls blood calcium levels. Primary hyperparathyroidism (PH) is a common disorder whereby one or more of these glands may enlarge and overproduce their hormone. Subsequently, the elevated blood calcium can cause many other symptoms and problems. The standard treatment is surgical removal of the gland(s) causing the disorder. The standard safe and effective operation has been the bilateral open parathyroid exploration (BOPE). A newer procedure using a radioactive compound that concentrates in the parathyroid glands allows a more limited operation to find and remove the causative gland [Minimally-Invasive Radioguided Parathyroidectomy (MIRP)]. The radiation exposure is minimal and safe. Although the operation may prove to be less expensive, it is not certain whether it is as effective or as safe as BOPE. This study serves to directly compare the costs, the effectiveness, and the safety associated with each type of operation. All patients (adolescents and older) with PH are candidates to participate. The participants will be randomly assigned to the MIRP group or the BOPE group independently of patient or physician preferences. MIRP patients will undergo a sestamibi nuclear medicine scan to attempt to localize the specific parathyroid gland causing the hyperparathyroidism and subsequently a limited operation under local anesthesia to remove the single gland. Parathyroid hormone levels will be measured during the operation to ensure that the patient has been cured. If not, the standard BOPE procedure will be completed. The total cost of the care will be tracked for each group. Careful testing for complications such as vocal cord dysfunction will be done. General Health status and pain levels will be measured before and after each operation. Patient satisfaction with the operation and care will also be assessed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism
Keywords
Radionuclide imaging, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive radioguided parathyroidectomy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elevated serum calcium concentration on at least 2 occasions; if the value is <11.0 mg/dL, it must have been present for at least 6 months; if the serum albumin concentration is not normal, the ionized calcium level will be measured and must be elevated.
Nephrolithiasis or documented bone mineral density less than 2.5 Standard Deviations below age matched means.
Elevated or non-suppressed serum intact parathyroid hormone level
Facility Information:
Facility Name
Univ. of Michigan Hosp, Dept. of Surgery
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0331
Country
United States
12. IPD Sharing Statement
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Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism
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