Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism: a randomized clinical trial
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Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism : a randomized clinical trial. / Lykke, Eva; Christensen, Anders; Juhl, Karina; Feldt-Rasmussen, Ulla; Friberg Hitz, Mette; Svenningsen Sjöstedt, Sannia Mia; Holst Hahn, Christoffer; Kraik Svensson, Ditte Maria; Kanstrup Springborg, Karoline; Stage, Mads Georg; Bjørn Hvilsom, Gitte; Hilsted, Linda Maria; Dahl, Morten; Lelkaitis, Giedrius; Kjaer, Andreas; Homøe, Preben; von Buchwald, Christian.
In: European Archives of Oto-Rhino-Laryngology, Vol. 280, 2023, p. 2593–2603.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism
T2 - a randomized clinical trial
AU - Lykke, Eva
AU - Christensen, Anders
AU - Juhl, Karina
AU - Feldt-Rasmussen, Ulla
AU - Friberg Hitz, Mette
AU - Svenningsen Sjöstedt, Sannia Mia
AU - Holst Hahn, Christoffer
AU - Kraik Svensson, Ditte Maria
AU - Kanstrup Springborg, Karoline
AU - Stage, Mads Georg
AU - Bjørn Hvilsom, Gitte
AU - Hilsted, Linda Maria
AU - Dahl, Morten
AU - Lelkaitis, Giedrius
AU - Kjaer, Andreas
AU - Homøe, Preben
AU - von Buchwald, Christian
N1 - Publisher Copyright: © 2023, The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
PY - 2023
Y1 - 2023
N2 - Purpose: The purpose of this single-blinded, 2-centre, randomized controlled trial was to test if near-infrared (NIR) autofluorescence image guidance for parathyroid gland (PG) detection during total thyroidectomy can reduce the incidence of hypoparathyroidism in both malignant and benign cases. Method: Patients admitted for primary or completion total thyroidectomy were randomized to either the NIR intervention group or the standard care NONIR (no near infrared) group. The primary endpoint was the rate of hypoparathyroidism at the 3-month follow-up, defined as hypocalcemia and inappropriately low parathyroid hormone levels and/or continuous treatment with active vitamin D. The secondary endpoint was the PG identification rate. Results: A total of 147 patients were included of whom 73 were allocated to NIR. Primary or completion thyroidectomy was conducted in 84 and 63 cases, respectively. A total of 130 completed 3 months follow-up. Postoperative hypoparathyroidism in the NIR group at 12 h, 1 month and 3 months was, respectively, 31.8, 14.1, 6.5% compared with 35.9, 18.9, 11.8% in the NONIR group (all p > 0.46). In the NIR group, the identification rate of PGs was 69.5% (146 of 210 PGs), and 9% (19 of 210 PGs) were identified only due to additional use of NIR. For 15 out of 69 patients (21.7%) additionally PGs was found. Conclusion: Hypoparathyroidism was nominally less frequent in the NIR group, although not statistically significant. Further studies are needed to confirm if NIR may be a supportive PG identification tool to minimize the number of PG which would have been otherwise missed, especially during more complicated thyroid procedures. Trial registry: ClinicalTrials.gov: NCT04193332. Registration date: 16.08.2019.
AB - Purpose: The purpose of this single-blinded, 2-centre, randomized controlled trial was to test if near-infrared (NIR) autofluorescence image guidance for parathyroid gland (PG) detection during total thyroidectomy can reduce the incidence of hypoparathyroidism in both malignant and benign cases. Method: Patients admitted for primary or completion total thyroidectomy were randomized to either the NIR intervention group or the standard care NONIR (no near infrared) group. The primary endpoint was the rate of hypoparathyroidism at the 3-month follow-up, defined as hypocalcemia and inappropriately low parathyroid hormone levels and/or continuous treatment with active vitamin D. The secondary endpoint was the PG identification rate. Results: A total of 147 patients were included of whom 73 were allocated to NIR. Primary or completion thyroidectomy was conducted in 84 and 63 cases, respectively. A total of 130 completed 3 months follow-up. Postoperative hypoparathyroidism in the NIR group at 12 h, 1 month and 3 months was, respectively, 31.8, 14.1, 6.5% compared with 35.9, 18.9, 11.8% in the NONIR group (all p > 0.46). In the NIR group, the identification rate of PGs was 69.5% (146 of 210 PGs), and 9% (19 of 210 PGs) were identified only due to additional use of NIR. For 15 out of 69 patients (21.7%) additionally PGs was found. Conclusion: Hypoparathyroidism was nominally less frequent in the NIR group, although not statistically significant. Further studies are needed to confirm if NIR may be a supportive PG identification tool to minimize the number of PG which would have been otherwise missed, especially during more complicated thyroid procedures. Trial registry: ClinicalTrials.gov: NCT04193332. Registration date: 16.08.2019.
KW - Hypocalcemia
KW - Hypoparathyroidism
KW - Near-infrared autofluorescence
KW - Parathyroid glands
KW - Thyroidectomy
U2 - 10.1007/s00405-023-07867-4
DO - 10.1007/s00405-023-07867-4
M3 - Journal article
C2 - 36853388
AN - SCOPUS:85148998852
VL - 280
SP - 2593
EP - 2603
JO - Archiv fur klinische und experimentelle Ohren- Nasen- und Kehlkopfheilkunde
JF - Archiv fur klinische und experimentelle Ohren- Nasen- und Kehlkopfheilkunde
SN - 0942-8992
ER -
ID: 339635653