Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542315
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism A Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEREGRINE
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
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None