Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism

What Was Tested

The trial (not phased) is built around Parathyroid Hormone (PTH 1-84) for 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.

It had five arms (groups): No IOPTH monitoring arm (no intervention), 10 minute arm (experimental), 15 minute arm (experimental), 20 minute arm (experimental) and 25 minute arm (experimental).

Surgery for patients randomized to this arm will not require guidance with any IOPTH monitoring. These will be allowed to use frozen section analysis, if deemed appropriate by the surgeon.

The registry classes the interventions as procedure.

More on the Plan

Intraoperative parathyroid hormone (IOPTH) monitoring, which is a surgical adjunct that uses the short half-life of PTH to guide parathyroid surgery, is standard-of-care in primary hyperparathyroidism.

There is no consensus nor standardization in the use of IOPTH monitoring in secondary and tertiary hyperparathyroidism.

To evaluate the feasibility of a fully powered trial, the investigators will conduct a randomized and blinded multi-centre, multi-arm pilot trial.

The investigators plan on evaluating five allocation arms that use four IOPTH monitoring criteria (i.e., 10 minutes, 15 minutes, 20 minutes, and 25 minutes) against a control arm of not using IOPTH monitoring.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: undergoing parathyroidectomy for primary hyperparathyroidism; pregnant or breastfeeding women; undergoing revision parathyroidectomy.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Parathyroid Hormone (PTH 1-84) and who got the comparison, which limits bias.

The Parathyroid Hormone (PTH 1-84) group and the comparison group ran side by side rather than switching.

As a double-blind Parathyroid Hormone (PTH 1-84) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2024-10 with completion listed for 2026-04.

It ran at 1 site in Canada.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Randomization rate (time frame: From enrollment to the end the trial at 6 months).

It also tracked 4 secondary outcomes, for example Surgeon compliance and crossover, Follow-up completion and Trial costs.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Parathyroid Hormone (PTH 1-84) in 60 people with hyperparathyroidism.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Parathyroid Hormone (PTH 1-84) compound page, Hyperparathyroidism research.