Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism (PEREGRINE): a protocol for a randomised multiarm surgical pilot trial.
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BACKGROUND: Secondary and tertiary renal hyperparathyroidism (RHPT) are common sequelae of chronic kidney disease and are associated with worse patient mortality and quality of life. Clinical guidelines remain lacking with regard to recommendations for using intraoperative parathyroid hormone (IOPTH) during surgery for RHPT. A prospective randomised study will help evaluate the role of IOPTH in guiding surgery for secondary and tertiary RHPT. METHODS/DESIGN: Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism is a pragmatic, multicentre, five-arm, parallel-group, patient-blinded and outcome assessor-blinded prospective pilot trial used to evaluate the feasibility of performing a definitive trial. Eligible participants include adult patients diagnosed with secondary or tertiary hyperparathyroidism who are candidates for subtotal or total parathyroidectomy. Consenting patients will be randomly assigned, through central allocation, in a 1:1:1:1:1 fashion to undergo surgery with IOPTH monitoring (four experimental arms: postexcision IOPTH samples taken at 10, 15, 20 or 25 min) or to undergo surgery without IOPTH monitoring (control arm). The primary feasibility objective is to estimate the percentage of eligible patients that are randomised: ≥70% proceed; 50-69% modify protocol before proceeding; <50% fail to proceed. Secondary feasibility outcomes include the percentage of enrolled participants with complete data at 6 months trial follow-up (ie, ≥90% proceed; 80-89% modify protocol before proceeding; <80% fail to proceed) and the recruitment rate during the trial (ie, ≥5 patients per month to proceed; 2-4 patients per month to modify protocol before proceeding; <2 patients per month to fail to proceed). We estimate that 60 patients will be needed to achieve the primary feasibility outcome. Descriptive analysis will be conducted for feasibility outcomes. The results of our pilot study will inform the feasibility of a definitive trial, and if no major changes to our protocol are indicated, we will treat this study as a vanguard trial and enrol the 60 pilot patients into the definitive trial. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Hamilton Integrated Research Ethics Board. Pilot trial results will be shared widely through local, national and international academic and clinical networks and will be disseminated through conference presentations and publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06542315, registered on 6 August 2024.
