Autofluorescence and Indocyanine Green to Avoid Hypocalcemia After Thyroidectomy

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

November 1, 2021

Primary Completion Date

October 31, 2024

Study Completion Date

May 31, 2025

Conditions
Thyroid DiseaseHypoparathyroidism Postprocedural
Interventions
DRUG

Autofluorescent detection + Injection of indocyanine green

"All four parathyroid glands will be actively sought for in every case selected for the use of AF/ICG, with AF verification of parathyroid tissue.~The timepoints of AF will be:~* 1 = after lateral dissection side 1 (side 1)~* 2= after lateral dissection side 2 (side 2)~The timepoints of ICG injection will be:~* 1 = after the first thyroid lobectomy (side 1)~* 2 = after the second thyroid lobectomy (side 2)~Scoring of the viability of parathyroid glands (adapted from Vidal Fortuny et al., 2016):~* 1 = black = not viable/vascularized~* 2 = grey = moderately viably/ moderately vascularized~* 3 = white = viable/well-vascularized"

PROCEDURE

Gold standard of visual identification and evaluation of viability of the parathyroid glands.

Gold standard of visual identification and evaluation of viability of the parathyroid glands.

Trial Locations (1)

9300

RECRUITING

Onze Lieve Vrouw Hospital, Aalst

All Listed Sponsors
lead

Onze Lieve Vrouw Hospital

OTHER