[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557761":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":12,"centralContacts":37,"locations":43,"responsibleParty":68,"collaborators":12,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":12,"enrollmentInfo":81,"targetDuration":12,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":98,"whyStopped":12,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"McMaster University","OTHER",[8,13,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"No IOPTH monitoring arm","NO_INTERVENTION","Surgery 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.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"10 minute arm","EXPERIMENTAL","Surgery 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.",[18],"Procedure: Intraoperative parathyroid hormone (IOPTH) monitoring",{"label":20,"type":15,"description":21,"interventionNames":22},"15 minute arm","Surgery 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.",[18],{"label":24,"type":15,"description":25,"interventionNames":26},"20 minute arm","Surgery 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.",[18],{"label":28,"type":15,"description":29,"interventionNames":30},"25 minute arm","Surgery 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.",[18],[32],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":12},"PROCEDURE","Intraoperative parathyroid hormone (IOPTH) monitoring","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.",[14,20,24,28],[38],{"name":39,"role":40,"phone":41,"phoneExt":12,"email":42},"Phillip Staibano, MD, MSc","CONTACT","905-929-1992","phillip.staibano@medportal.ca",[44],{"facility":45,"status":12,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"St Joseph's Hospital","Hamilton","Ontario","L8N 3K7","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-79.84963,43.25011,{"lat":55,"lon":54},[58,61,66],{"name":59,"role":40,"phone":60,"phoneExt":12,"email":42},"Phillip Staibano, MD MSc","905 929 1992",{"name":62,"role":40,"phone":63,"phoneExt":64,"email":65},"Michael Au, MD FRCSC","905.521.2100","35036","aum@stjosham.on.ca",{"name":59,"role":67,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Phillip Staibano","Physician, Resident surgeon","100557761","intraoperative-parathyroid-hormone-monitoring-to-guide-surgery-in-renal-hyperparathyroidism-100557761",false,"NCT06542315","Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism","Intraoperative Parathyroid Hormone Monitoring to Guide Surgery in Renal hyperparathyroIdism: A Pilot Trial","PEREGRINE","Inclusion Criteria:\n\n* 18 years of age or older\n* Candidate for subtotal parathyroidectomy or total thyroidectomy with or without autotransplantation\n* Tertiary hyperparathyroidism and\u002For recurrent hyperparathyroidism OR secondary hyperparathyroidism diagnosed with any stage of chronic kidney disease\n\nExclusion Criteria:\n\n* Undergoing parathyroidectomy for primary hyperparathyroidism\n* Pregnant or breastfeeding women\n* Undergoing revision parathyroidectomy\n* Undergoing minimally invasive or video-assisted parathyroidectomy\n* Unable to provide written consent to be participant in study\n* Unable to complete study follow-up visits","ALL","18 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"NA","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:\n\nIs a fully powered trial investigating the role for IOPTH criteria in secondary and tertiary hyperparathyroidism feasible?\n\nThe comparison group is surgery not guided by IOPTH.\n\nParticipants 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.",[89,90],"Secondary Hyperparathyroidism","Tertiary Hyperparathyroidism",[92,93,94,95,96,97],"hyperparathyroidism","secondary hyperparathyroidism","tertiary hyperparathyroidism","chronic kidney disease","renal transplantation","pilot trial","NOT_YET_RECRUITING","2024-08-04",{"date":101,"type":102},"2024-08-07","ACTUAL",{"date":104,"type":83},"2024-10",{"date":106,"type":83},"2026-06",{"name":5,"class":6},1]