Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006329
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-10-04
Brief Title:
Comparison of Two Methods of Parathyroidectomy for Primary Hyperparathyroidism
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 glands 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000042 | NIH | None | httpsreporternihgovquickSearchM01RR000042 |