Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism
NCT Number: NCT06542315
Acronym: PEREGRINE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Secondary Hyperparathyroidism|Tertiary Hyperparathyroidism
Interventions: PROCEDURE: Intraoperative parathyroid hormone (IOPTH) monitoring
Sponsor: McMaster University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-10
Completion Date: 2026-06
Locations: St Joseph's Hospital, Hamilton, Ontario, L8N 3K7, Canada

Summary:
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.

Primary Outcome Measures: Randomization rate, Defined as the number of patients agreeing to participate in the trial and being randomized to any of the allocation groups, divided by the number of eligible patients. We will review this data every two weeks during the pilot trial. A randomization percentage of 70% or greater will support the feasibility of a fully powered RCT. We will utilize the traffic light system introduced by Avery and colleagues, whereby if randomization of 70% or greater is achieved, we will proceed with fully powered trial. If a randomization rate of 50-69% is achieved, we will consider proceeding with modifications to the fully powered trial. If randomization rate is \<50%, we will not proceed with fully powered trial. We selected this as a primary feasibility outcome because we are sampling from a relatively rare population, and so gathering an accurate estimate of randomization rate will allow us to determine the ideal number of participating sites for the final trial., From enrollment to the end the trial at 6 months
Secondary Outcome Measures: Blinding effectiveness, The Bang Blindness Inventory (BBI) will be administered to patients, outcome assessors, and statisticians at the end of study follow-up and the time of trial completion (for statisticians). The BBI will then be calculated for each of these blinded parties and reported on a scale of -1 (unblinding) to 0 (perfect blinding) to +1 (lack of blinding)., From enrollment to the end the trial at 6 months|Surgeon compliance and crossover, Surgeon compliance and crossover: The number of patients who undergo surgery with a different IOPTH monitoring criteria from which they were randomized. All surgeons will complete a postoperative de-brief form that will capture their rationale for changing groups. We will consider any percentage of group crossover to hinder consideration of a fully powered trial and based on the direction and number of groups crossovers. If any crossovers are detected, then we will consider to the number and organization of allocation arms for the fully powered trial., From enrollment to the end the trial at 6 months|Follow-up completion, Defined as completion of all questionnaires and study bloodwork from randomization to final study follow-up., From enrollment to the end the trial at 6 months|Trial costs, We will estimate the study and hospital costs required for this multi-centre initiative for each recruited patient during the study period. This will provide an estimate of the costs for performing the fully powered trial., From enrollment to the end the trial at 6 months
Other Outcome Measures: Surgeon-dictated changes to intraoperative plan, Any changes to the surgical plan will be documented by surgeons in a postoperative de-brief form., From enrollment to the end the trial at 6 months|Operating time, The length of the surgery from skin incision to skin closure, as measured in minutes, From enrollment to the end the trial at 6 months|Revision surgery rate and indication for revision surgery, Number of patients who either undergo or are consented and scheduled to undergo revision parathyroidectomy within 6 months of randomization. This will be measured as a dichotomous outcome. We will also evaluate the surgical indication for revision surgery. This will be measured as a categorical outcome., From enrollment to the end the trial at 6 months|Chronic kidney disease progression, cardiovascular death, or renal death (composite outcome), Number of patients who meet the criteria of this composite outcome (sustained decline in eGFR of at least 50%, end-stage kidney disease, or kidney-related or cardiovascular death)., From enrollment to the end the trial at 6 months|Recurrent and/or persistent hyperparathyroidism rates, Number of people who continue to have pathologically elevated PTH levels within 3 months of randomization. This will be measured with reference to the defined PTH reference threshold at each participating institution. This will be measured immediately after surgery and at one month and six months from randomization. We will also measure the number of patients who have laboratory hypercalcemia as defined by bloodwork immediately after surgery and at one month and six months from randomization., From enrollment to the end the trial at 6 months|IOPTH kinetics in secondary and tertiary hyperparathyroidism, The IOPTH change (as a percent) between time points will be described., From enrollment to the end the trial at 6 months|Emergency room visits and hospital readmission rates, Number of emergency room visits and hospital readmissions due to surgical complications., From enrollment to the end the trial at 6 months|Length of hospital stay, Number of days admitted to hospital from the date of surgery to the day of hospital discharge. We will also measure the length of hospital stay for any readmissions from hospital admission to discharge., From enrollment to the end the trial at 6 months|Health-related quality of life, These will be measured using the SF-36 tool and kidney disease quality of life (KDQOL)-36 tool prior to randomization (baseline), and at one month and three months from surgery. The SF-36 is a validated self-reported patient-centred outcome measure (PROM) measured via eight domains on a 0-100 scale with lower scores indicating worse disability. The KDQOL-36 is a validated self-reported PROM scored from 0-100 with higher scores indicating better quality of life., From enrollment to 3 months|Renal graft failure and renal graft complication rates, Number of patients who have renal transplantation who experienced renal graft failure and/or complication during the study period., From enrollment to the end the trial at 6 months|Rates of hypoparathyroidism and hypocalcemia, These will be measured by calculating the number of patients who develop hypoparathyroidism and/or hypocalcemia following surgery., From enrollment to the end the trial at 6 months|Surgery-specific complication rates, The types of surgical complications will be documented., From enrollment to the end the trial at 6 months|Fully powered trial costs, This will be collected during the study period. It will include operative and inpatient/outpatient costs for each randomized patient., From enrollment to the end the trial at 6 months|Cognitive function, These will be measured using the Hospital Anxiety and Depression Scale (HADS) and MoCA prior to randomization (baseline), and at one month and three months postoperatively. In the HADS, higher scores indicate worse anxiety and depression scores with scores ranging from 0-21. In the MoCA, lower scores indicate worse cognitive function with scores ranging from 0-30., From enrollment to 3 months