Indocyanine green angiography-guided thyroidectomy versus conventional thyroidectomy for preserving parathyroid function: study protocol for a randomized single-blind controlled trial

Abstract

IntroductionAngiography with indocyanine green (ICG) fluorescence performed before thyroidectomy would allow identification of the vascularization of parathyroid glands, maximizing efforts for preserving functioning glands intraoperatively. The rationale of the study was based on the hypothesis that showing the vascular pattern of the parathyroid glands by means of ICG angiography before performing the thyroidectomy could prevent permanent hypoparathyroidism.Methods and analysisWe propose a randomized single-blind controlled and multicenter clinical trial to assess the efficacy and safety of ICG angiography-guided thyroidectomy to identify the vascular pattern of the parathyroid glands versus conventional thyroidectomy in patients scheduled for elective total thyroidectomy. Patients will be randomized 1:1 to ICG angiography-guided thyroidectomy (experimental group) or conventional thyroidectomy (control group). Patients in the experimental group will undergo ICG angiography before thyroidectomy to identify the feeding vessels of the parathyroid glands and then, post-thyroidectomy ICG angiography to predict immediate parathyroid gland function by scoring the degree of fluorescence of the glands. Patients in the control group will undergo post-thyroidectomy ICG angiography only. The primary outcome measure will be the rate of patients with permanent hypoparathyroidism. Secondary outcome measures will be rate of postoperative hypoparathyroidism, the percentage of well vascularized parathyroid glands remaining in situ, the levels of iPTH and serum calcium after surgery and the influence of the type of vascular pattern of the parathyroid glands over these outcomes, as well as the safety profile of ICG angiography.DiscussionThe results will contribute to adopt a new surgical strategy based on intraoperative ICG angiography before performing total thyroidectomy, according to which the rate of permanent hypoparathyroidism could be substantially reduced.Clinical trial registrationClinicalTrials.gov. identifier NCT05573828.

Indocyanine green (ICG) angiography-guided thyroidectomy: description of surgical technique

“…In conclusion, this report aims to introduce ICG angiography-guided thyroidectomy, an innovative surgical technique that has allowed decreasing the rates of hypoparathyroidism in our center. These promising preliminary results should be confirmed in a randomized single-blind controlled multicenter trial, the results of which will strongly support to adopt this new surgical strategy in the field of thyroid surgery ( 28 ).…”

Silicon-Rhodamine Functionalized Evocalcet Probes Potently and Selectively Label Calcium Sensing Receptors In Vitro, In Vivo, and Ex Vivo

“…Currently the relatively high far-red autofluorescence of the parathyroid glands compared to the surrounding tissues is used for parathyroid gland identification, which does not inform surgeons about the perfusion and the vitality of the glands during the operation . For parathyroid gland perfusion, indocyanine green angiography can be applied, which is an aspecific label . Although the recently developed structure-inherent probe, T800-F that is specifically taken up by the parathyroid glands is chemically more compact, its flexibility to optimize for clinical use (DMPK, toxicity) might be limited .…”

“…49 For parathyroid gland perfusion, indocyanine green angiography can be applied, which is an aspecific label. 50 Although the recently developed structureinherent probe, T800-F that is specifically taken up by the parathyroid glands is chemically more compact, its flexibility to optimize for clinical use (DMPK, toxicity) might be limited. 51 The application of small-molecule CaSR-specific probes like EvoSiR4 for fluorescence-guided thyroidectomy could therefore help in both PG identification and assessment of PG perfusion of the surrounding vasculature.…”

Intraoperative near-infrared fluorescence visualization of anatomical structures in general surgical and urological practice

“…Suh et al вивчали можливість застосовувати індоціанін зелений як флуоресцентний агент у ближньому інфрачервоному діапазоні для ідентифікації паращитовидних залоз під час операції на щитовидній залозі [21]. Надалі у клінічних дослідженнях доведено, що автофлуоресценція ближнього інфрачервоного діапазону та ICG-флуоресценція є ефективними інструментами для покращення післяопераційної функції паращитовидної залози під час операції на щитовидній залозі [22,23,24,25].…”