Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hypocalcemia
- Hypoparathyroidism Postprocedural
- Surgery- Complications
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to: Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence. Control: Conventional thyroidectomy and parathyroid identification b...
Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to: Intervention: NIR optic imaging assisted identification of the parathyroid glands during thyroidectomy using parathyroid gland autofluorescence. 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.
Tracking Information
- NCT #
- NCT04193332
- Collaborators
- Cluster for molecular imaging, Denmark
- Dept of Otorhinolaryngology and Maxillofacial Surgery, Zealand University Hospital, Denmark
- Investigators
- Study Director: Christian von Buchwald, MD, MDSc, PhD Rigshospitalet, Denmark
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