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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01974 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 274915 | Other Identifier | Roswell Park Cancer Institute |
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This clinical trial studies the omission of intact parathyroid hormone testing during surgery in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone testing during parathyroid gland removal may help patients with primary hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time and cost of surgery.
PRIMARY OBJECTIVES:
I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing).
SECONDARY OBJECTIVES:
I. Cost-analysis to determine savings of omission of intraoperative PTH testing.
OUTLINE:
Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.
After completion of study, patients are followed up at 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive Care (parathyroidectomy) | Experimental | Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboratory Biomarker Analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission | Will be evaluated using a binomial exact test. If all N=60 patients achieve cure then the proposed surgery with intraoperative PTH testing committed will be considered non inferior. A 95% confidence interval about pi will be obtained. | At 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative cost analysis | cost analysis will be based on operative time and omission of intraoperative PTH levels. | At 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moshim Kukar | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Parathyroidectomy |
| Procedure |
Undergo parathyroidectomy |
|
| ID | Term |
|---|---|
| D010282 | Parathyroid Neoplasms |
| D049950 | Hyperparathyroidism, Primary |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004700 | Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
| D006961 | Hyperparathyroidism |
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| ID | Term |
|---|---|
| D016105 | Parathyroidectomy |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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