Researchers are evaluating whether intraoperative parathyroid hormone monitoring can improve surgical outcomes for patients undergoing parathyroidectomy due to secondary or tertiary renal hyperparathyroidism in a randomized pilot trial in Canada.
Specifically, they are testing the feasibility of using intraoperative parathyroid hormone (IOPTH) at different time intervals to help surgeons confirm complete removal of hyperfunctioning parathyroid tissue. The trial’s primary goal is to determine whether at least 70% of eligible patients can be successfully randomized. This threshold would indicate feasibility for a larger, definitive trial. Secondary outcomes include a follow-up completion rate of 90% or higher and a monthly recruitment rate of at least 5 patients.
The five-arm trial targets 60 patients at high-volume endocrine surgery hospitals in Hamilton, Toronto, and Brantford, Ontario who are randomized equally to receive IOPTH monitoring at 10, 15, 20, or 25 minutes after gland excision, or no IOPTH monitoring at all. All participants will undergo bilateral neck exploration and removal of either 3.5 or all 4 parathyroid glands. Inclusion criteria require patients to be at least 18 years old with a diagnosis of secondary or tertiary renal hyperparathyroidism (RHPT). Patients undergoing revision, minimally invasive, autofluorescence-guided, or radioguided surgery are excluded.
In the experimental arms, surgical success is defined as a 50% or greater drop in IOPTH compared with the highest pre-excision baseline. If this threshold is not reached at the assigned timepoint, surgeons are advised to re-explore the neck for remaining tissue. In the control group, surgeons may use frozen section analysis at their discretion. All patients are followed for 6 months after surgery. Outcomes include rates of persistent or recurrent hyperparathyroidism and complications such as recurrent laryngeal nerve injury, hypocalcemia, or hypoparathyroidism. Researchers will also assess patient-reported outcomes, including quality of life and cognitive function. Cost-effectiveness data will be collected across all arms. Outcome assessors are blinded to group assignments.
The study's design reflects real-world clinical settings and allows flexibility in imaging and intraoperative techniques. "The PEREGRINE pilot trial will be important in gathering information about present-day management, but additional work will be needed to account for evolving parathyroid surgeon practices when designing the definitive trial," such as the use of parathyroid autofluorescence, lead author Phillip Staibano, of the Division of Otolaryngology–Head and Neck Surgery, Department of Surgery and Department of Health Research Methodology, Evidence, and Impact at McMaster University in Hamilton, Ontario, Canada, wrote with colleagues.
Enrollment began in February 2025. If feasibility targets are met, the 60 patients in the pilot may be included in the full trial without protocol modification. The researchers expect trial reporting to occur in the first quarter of 2027.
The authors reported no conflicts of interest.
Source: BMJ Open