Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism
PEREGRINE
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 7, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedAugust 7, 2024
August 1, 2024
1.5 years
July 30, 2024
August 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Blinding effectiveness
From enrollment to the end the trial at 6 months
Surgeon compliance and crossover
From enrollment to the end the trial at 6 months
Follow-up completion
From enrollment to the end the trial at 6 months
Trial costs
From enrollment to the end the trial at 6 months
Other Outcomes (14)
Surgeon-dictated changes to intraoperative plan
From enrollment to the end the trial at 6 months
Operating time
From enrollment to the end the trial at 6 months
Revision surgery rate and indication for revision surgery
From enrollment to the end the trial at 6 months
- +11 more other outcomes
Study Arms (5)
No IOPTH monitoring arm
NO INTERVENTIONSurgery for patients randomized to this arm will not require guidance with any IOPTH monitoring. These will be allowed to use frozen section analysis, if deemed appropriate by the surgeon.
10 minute arm
EXPERIMENTALSurgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 10 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.
15 minute arm
EXPERIMENTALSurgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 15 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.
20 minute arm
EXPERIMENTALSurgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 20 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.
25 minute arm
EXPERIMENTALSurgery for patients randomized to this arm will need to use IOPTH monitoring. Surgeons in this arm will decide to end surgery or perform surgical re-exploration if the IOPTH level at 25 minutes following ligation of all hyperfunctioning parathyroid tissue is \>=50% from the highest pre-incision or pre-excision baseline IOPTH level.
Interventions
Intraoperative parathyroid hormone (IOPTH) monitoring, which is a surgical adjunct that permits PTH bloodwork to be drawn during parathyroid surgery to monitor and guide surgical outcomes.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Joseph's Hospital
Hamilton, Ontario, L8N 3K7, Canada
Related Publications (2)
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.
PMID: 35529086RESULTStaibano P, Au M, Pasternak JD, Parpia S, Zhang H, Busse JW, Nguyen NT, Monteiro E, Gupta MK, Choi DL, Lewis T, McKechnie T, Thabane A, Ham J, Young JE, Bhandari M. Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism (PEREGRINE): a protocol for a randomised multiarm surgical pilot trial. BMJ Open. 2025 Jul 17;15(7):e098860. doi: 10.1136/bmjopen-2025-098860.
PMID: 40675640DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Statisticians
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician, Resident surgeon
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 7, 2024
Study Start
October 1, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
August 7, 2024
Record last verified: 2024-08