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NCT00006329 · ClinicalTrials.gov registry record · Phase 2
Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism
A Phase 2 study, sponsored by National Center for Research Resources (NCRR).
- Completed
- Registry status
- Phase 2
- Development phase
NCT00006329 is a Phase 2 study that has completed, run by National Center for Research Resources (NCRR).
The verdict
NCT00006329, a Phase 2 study, has completed, sponsored by National Center for Research Resources (NCRR).
- COMPLETED
- Registry status
- Phase 2
- Development phase
Study 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.
Interventions
- PROCEDURE Minimally invasive radioguided parathyroidectomy
Trial Details
| Field | Value |
|---|---|
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006329
The ClinicalTrials.gov registry entry for NCT00006329 describes a study currently listed as completed, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Minimally invasive radioguided parathyroidectomy is the first listed.
NCT00006329 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006329 about?
NCT00006329 is a clinical study titled "Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism". 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...
What is the current status of trial NCT00006329?
This trial is currently completed. It is a Phase 2 study.
What interventions are being tested in trial NCT00006329?
The interventions under investigation include: Minimally invasive radioguided parathyroidectomy (PROCEDURE).
Who is sponsoring clinical trial NCT00006329?
This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.
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