Evidence map›Paper›PMID 40675640›Full record

ArticleBMJ open2025

Intraoperative parathyroid hormone monitoring to guide surgery in renal hyperparathyroidism (PEREGRINE): a protocol for a randomised multiarm surgical pilot trial.

Phillip Staibano, Michael Au, Jesse D Pasternak, Sameer Parpia, Han Zhang, Jason W Busse, Nhu-Tram Nguyen, Eric Monteiro, Michael K Gupta, David L Choi and 6 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06542315 (Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06542315 nanot yet recruitingnot on this map

Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism: A Pilot Trial

TypeinterventionalSponsorMcMaster UniversityRan2024 to 2026Enrolled60ConditionsSecondary Hyperparathyroidism, Tertiary HyperparathyroidismArmsIntraoperative parathyroid hormone (IOPTH) monitoring
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Phillip StaibanoDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada phillip.staibano@medportal.ca.ORCID http://orcid.org/0000-0002-9095-9543
Michael AuDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Jesse D PasternakDepartment of Surgery, University Health Network, Toronto, Ontario, Canada.
Sameer ParpiaDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Han ZhangDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Jason W BusseDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID http://orcid.org/0000-0002-0178-8712
Nhu-Tram NguyenDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Eric MonteiroDepartment of Otolaryngology-Head and Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
Michael K GuptaDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
David L ChoiDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Trevor LewisDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Tyler McKechnieDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.ORCID http://orcid.org/0000-0002-7668-4096
Alex ThabaneDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Jennifer HamDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
J E YoungDivision of Otolaryngology-Head and Neck Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Mohit BhandariDepartment of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSecondary 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/

designIntraoperative 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.

Indexed as

Hyperparathyroidism, SecondaryMonitoring, IntraoperativeParathyroidectomyParathyroid HormoneRenal Insufficiency, ChronicAdultFeasibility StudiesFemaleHumansMaleMulticenter Studies as TopicPilot ProjectsPragmatic Clinical Trials as TopicProspective StudiesRandomized Controlled Trials as TopicParathyroid HormoneClinical ProtocolsEndocrine tumoursHead & neck surgeryPragmatic Clinical TrialSURGERY

Identifiers

PMID40675640
PMCPMC12273077

What Socratic holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.