Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
NCT ID: NCT04193332
Last Updated: 2022-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
214 participants
INTERVENTIONAL
2019-08-16
2023-12-01
Brief Summary
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Detailed Description
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1. Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence.
2. Control: Conventional thyroidectomy and parathyroid identification by the surgeon.
Measurements:
PTH and ionized-Ca blood samples are collected preoperatively, within 12 hours postoperatively and at 1-, 3-, 9- and 12-months follow-up.
Anticipated 214 patients are included, all of which participate in 3 months follow-up. Only patients with persistent hypoparathyroidism at this point continue til maximum 12 months follow-up.
An interim analysis will be conducted when inclusion of anticipated 128 patients and 3 months follow-up is reached.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Plus NIR optical imaging
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery
NIR optical imaging camera
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
Minus NIR optical imaging
Conventional identification of parathyroid glands during thyroid surgery
No interventions assigned to this group
Interventions
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NIR optical imaging camera
NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
Eligibility Criteria
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Inclusion Criteria
* Patients admitted to either total thyroidectomy og completion thyroidectomy, both benign and malign.
Exclusion Criteria
* Previous parathyroid surgery or other parathyroid decease
* Age under 18
18 Years
ALL
No
Sponsors
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Cluster for molecular imaging, Denmark
UNKNOWN
Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
UNKNOWN
Rigshospitalet, Denmark
OTHER
Responsible Party
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Eva Lykke
Principal investigator
Principal Investigators
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Christian von Buchwald, MDSc, PhD
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
Køge, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Abbaci M, De Leeuw F, Breuskin I, Casiraghi O, Lakhdar AB, Ghanem W, Laplace-Builhe C, Hartl D. Parathyroid gland management using optical technologies during thyroidectomy or parathyroidectomy: A systematic review. Oral Oncol. 2018 Dec;87:186-196. doi: 10.1016/j.oraloncology.2018.11.011. Epub 2018 Nov 16.
Dip F, Falco J, Verna S, Prunello M, Loccisano M, Quadri P, White K, Rosenthal R. Randomized Controlled Trial Comparing White Light with Near-Infrared Autofluorescence for Parathyroid Gland Identification During Total Thyroidectomy. J Am Coll Surg. 2019 May;228(5):744-751. doi: 10.1016/j.jamcollsurg.2018.12.044. Epub 2019 Jan 31.
Benmiloud F, Rebaudet S, Varoquaux A, Penaranda G, Bannier M, Denizot A. Impact of autofluorescence-based identification of parathyroids during total thyroidectomy on postoperative hypocalcemia: a before and after controlled study. Surgery. 2018 Jan;163(1):23-30. doi: 10.1016/j.surg.2017.06.022. Epub 2017 Nov 6.
Lykke E, Christensen A, Juhl K, Feldt-Rasmussen U, Friberg Hitz M, Svenningsen Sjostedt SM, Holst Hahn C, Kraik Svensson DM, Kanstrup Springborg K, Stage MG, Bjorn Hvilsom G, Hilsted LM, Dahl M, Lelkaitis G, Kjaer A, Homoe P, von Buchwald C. Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism: a randomized clinical trial. Eur Arch Otorhinolaryngol. 2023 May;280(5):2593-2603. doi: 10.1007/s00405-023-07867-4. Epub 2023 Feb 28.
Other Identifiers
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H19010211
Identifier Type: -
Identifier Source: org_study_id
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