Clinical trial NCT06542315: Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism
Official title: Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism: A Pilot Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Secondary Hyperparathyroidism
Tertiary Hyperparathyroidism
Keywords: hyperparathyroidism
secondary hyperparathyroidism
tertiary hyperparathyroidism
chronic kidney disease
renal transplantation
pilot trial
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-arm parallel group pilot trial
Primary purpose: OTHER

Brief 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.

Detailed description: Chronic kidney disease (CKD) is increasing in prevalence globally alongside rising rates of obesity and metabolic syndromes. The rates of secondary and tertiary hyperparathyroidism are expected to rise alongside the increasing prevalence of CKD. Secondary hyperparathyroidism is diagnosed in up to 80% of patients with long-standing CKD on hemodialysis and is associated worse renal and cardiovascular outcomes and quality of life. Up to 55% of patients are non-compliant with, or refractory to, medical treatment and therefore require definitive surgery. Up to 22% of patients who undergo renal transplantation also develop tertiary hyperparathyroidism, which is associated with worse patient morbidity and renal graft outcomes. Surgery to extirpate abnormal parathyroid tissue in both diagnoses is technically challenging with surgical failure rates as high as 30%. 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. The investigators propose a multi-centre, multi-arm randomized trial to identify the most effective IOPTH monitoring criteria in improving surgical outcomes 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. The primary feasibility outcome is randomization rate. The investigators will aim for a targeted randomization rate of 70% (95% CI: 55%-82%). Secondary feasibility outcomes include group cross-over rate, blinding effectiveness, patient compliance, and pilot trial costs. The primary efficacy outcome is recurrent hyperparathyroidism, which is evaluated at six months. Secondary efficacy outcomes will include operating room time, renal graft outcomes, renal function, cardiovascular outcomes, hospital admission and rate of re-admission, quality of life, cognitive performance. Inclusion criteria will include any adult patients (\&gt;= 18 years old) diagnosed with secondary or tertiary hyperparathyroidism who are candidates for parathyroid surgery.

The investigators plan to recruit 60 patients (12 per arm) to evaluate a randomization goal of 70% (95% CI: 55%-82%) while accounting for a 20% attrition rate. The investigators will perform descriptive analyses with ITT principles to evaluate feasibility and use these findings to evaluate the practicality of a fully powered trial. The investigators will perform descriptive analyses for all outcomes with 95% confidence intervals. The investigators will use the stop light model for determining whether a final trial is feasible, whereby a randomization rate equal to or greater than 70% will suggest that such a trial is feasible.

The results of a fully powered trial will standardize and identify the role for IOPTH monitoring in optimizing surgical outcomes for secondary and tertiary hyperparathyroidism.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Undergoing parathyroidectomy for primary hyperparathyroidism
* Pregnant or breastfeeding women
* Undergoing revision parathyroidectomy
* Undergoing minimally invasive or video-assisted parathyroidectomy
* Unable to provide written consent to be participant in study
* Unable to complete study follow-up visits

Primary outcomes:
measure: Randomization rate
timeFrame: From enrollment to the end the trial at 6 months
Secondary outcomes:
measure: Blinding effectiveness
timeFrame: From enrollment to the end the trial at 6 months
measure: Surgeon compliance and crossover
timeFrame: From enrollment to the end the trial at 6 months
measure: Follow-up completion
timeFrame: From enrollment to the end the trial at 6 months
measure: Trial costs
timeFrame: From enrollment to the end the trial at 6 months
Other outcomes:
measure: Surgeon-dictated changes to intraoperative plan
timeFrame: From enrollment to the end the trial at 6 months
measure: Operating time
timeFrame: From enrollment to the end the trial at 6 months
measure: Revision surgery rate and indication for revision surgery
timeFrame: From enrollment to the end the trial at 6 months
measure: Chronic kidney disease progression, cardiovascular death, or renal death (composite outcome)
timeFrame: From enrollment to the end the trial at 6 months
measure: Recurrent and/or persistent hyperparathyroidism rates
timeFrame: From enrollment to the end the trial at 6 months
measure: IOPTH kinetics in secondary and tertiary hyperparathyroidism
timeFrame: From enrollment to the end the trial at 6 months
measure: Emergency room visits and hospital readmission rates
timeFrame: From enrollment to the end the trial at 6 months
measure: Length of hospital stay
timeFrame: From enrollment to the end the trial at 6 months
measure: Health-related quality of life
timeFrame: From enrollment to 3 months
measure: Renal graft failure and renal graft complication rates
timeFrame: From enrollment to the end the trial at 6 months
measure: Rates of hypoparathyroidism and hypocalcemia
timeFrame: From enrollment to the end the trial at 6 months
measure: Surgery-specific complication rates
timeFrame: From enrollment to the end the trial at 6 months
measure: Fully powered trial costs
timeFrame: From enrollment to the end the trial at 6 months
measure: Cognitive function
timeFrame: From enrollment to 3 months
Locations:
city: Hamilton
country: Canada
facility: St Joseph's Hospital
state: Ontario
Study officials:
References:
citation: Kovesdy CP. Epidemiology of chronic kidney disease: an update 2022. Kidney Int Suppl (2011). 2022 Apr;12(1):7-11. doi: 10.1016/j.kisu.2021.11.003. Epub 2022 Mar 18.