Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University
About this trial
The goal of this pilot clinical is to determine the feasibility of a fully powered clinical trial to determine the effectiveness of intraoperative parathyroid hormone (IOPTH) criteria in guiding surgery for secondary and tertiary hyperparathyroidism. The main question it aims to answer is:
Is a fully powered trial investigating the role for IOPTH criteria in secondary and tertiary hyperparathyroidism feasible?
The comparison group is surgery not guided by IOPTH.
Participants will be randomized to undergo parathyroid surgery with one of four IOPTH criteria or a control arm that does not use IOPTH. All recruited patients are asked to complete quality of life and cognitive questionnaires, in addition to bloodwork during the study period.
Eligibility criteria
Qualifiers
18 years of age or older
Candidate for subtotal parathyroidectomy or total thyroidectomy with or without autotransplantation
Tertiary hyperparathyroidism and/or recurrent hyperparathyroidism OR secondary hyperparathyroidism diagnosed with any stage of chronic kidney disease
Disqualifiers
Undergoing parathyroidectomy for primary hyperparathyroidism
Pregnant or breastfeeding women
Undergoing revision parathyroidectomy
Undergoing minimally invasive or video-assisted parathyroidectomy
Trial design
Treatments tested in this trial
- Intraoperative parathyroid hormone (IOPTH) monitoring
Treatment groups
60 Participants
are divided into 5 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov