Clinical trial · Interventional
Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism
Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for Primary Hyperparathyroidism
NCT03011736CI-TRIAL-00053248completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parathyroid Gland Adenoma | Parathyroid Gland Adenoma | ONTOLOGY_EXACT | 0.98 |
| Primary Hyperparathyroidism | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Parathyroidectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive Care (parathyroidectomy)
- description
- Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Procedure: Parathyroidectomy
Primary outcomes (1)
- measure
- Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission
- timeFrame
- At 2 weeks
- description
- 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.
Secondary outcomes (1)
- measure
- Post-operative cost analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Positive 4 dimensional computed tomography (4D CT) for single gland (adenoma) primary hyperparathyroidism * Preoperative serum calcium levels \>= 10.9 mg/dL * Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately high for associated calcium level * Patient has no history of prior neck surgery or external radiation to neck for malignant conditions * Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2 * Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patient has recurrent hyperparathyroidism * 4D CT positive for multiple gland disease * Patient has inability to tolerate 4D CT scan (for example; contrast intravenous (IV) allergy, claustrophobia, renal disease) * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female subjects; may be determined in the preoperative evaluation * Unwilling or unable to follow protocol requirements * Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography \[EKG\], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)
References
Publications (0)
Data not yet available
No reference posted for this study.