Near Infrared (NIR) Autofluorescence Image-guided Thyroid Surgery

Status Recruiting

Clinical Trial Summary

The objective of this ongoing randomized controlled trial is to examine whether the use of intra-operative NIR(near infrared) camera can reduce the number of patients who experience transient or persistent hypoparathyroidism after total thyroidectomy and completion thyroidectomy, both in malignant and benign thyroid disease.

Clinical Trial Description

Patients admitted to total thyroidectomy or completion thyroidectomy is ramdomized to: 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. ;

Study Design

Related Conditions & MeSH terms

Hypocalcemia
Hypoparathyroidism
Hypoparathyroidism Postprocedural
Surgery--Complications

Clinical Trial Details

NCT number	NCT04193332
Study type	Interventional
Source	Rigshospitalet, Denmark
Contact	Eva Lykke, MD
Phone	+45 35454799
Email	eva.lykke@regionh.dk
Status	Recruiting
Phase	N/A
Start date	August 16, 2019
Completion date	December 1, 2023

View Details

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