Dataset Information

Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism: a randomized clinical trial.

ABSTRACT:

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.

SUBMITTER: Lykke E

PROVIDER: S-EPMC9971666 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism: a randomized clinical trial.

Lykke Eva E Christensen Anders A Juhl Karina K Feldt-Rasmussen Ulla U Friberg Hitz Mette M Svenningsen Sjöstedt Sannia Mia SM Holst Hahn Christoffer C Kraik Svensson Ditte Maria DM Kanstrup Springborg Karoline K Stage Mads Georg MG Bjørn Hvilsom Gitte G Hilsted Linda Maria LM Dahl Morten M Lelkaitis Giedrius G Kjaer Andreas A Homøe Preben P von Buchwald Christian C

European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery 20230228 5

<h4>Purpose</h4>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.<h4>Method</h4>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 ...[more]

PMID: 36853388

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Project description:BackgroundThe core goal of this article is to find some meaningful risk factors that can affect the postoperative hypoparathyroidism of thyroid cancer, create an effective prediction model on this basis, and use it to selectively implement routine prophylactic calcium supplementation for patients after thyroid carcinoma surgery.MethodsThe clinicopathological characteristics of patients with papillary thyroid carcinoma (PTC) who underwent conventional bilateral total thyroidectomy (TT) + bilateral central lymph node dissection from January 2020 to August 2021 in the Affiliated Hospital of Nantong University were retrospectively analyzed. Firstly, this study analyzed the relationship between postoperative hypocalcemia and hypoparathyroidism. Then, we included many potential risk factors such as gender, age, body mass index (BMI), lateral lymph node dissection (LLND) and so on and also performed univariate and multivariate analysis of the independent risk factors for postoperative hypoparathyroidism in patients, and established a predictive scoring model.ResultsAmong the 401 patients with PTC, 50.1% developed postoperative hypoparathyroidism. There was significant difference in serum calcium concentration between normal parathyroid group and hypoparathyroidism group after thyroid carcinoma surgery. BMI <24 kg/m2, lateral lymph node dissection, multifocality, and extrathyroidal extension (ETE) were all identified as independent risk factors for postoperative hypoparathyroidism. Based on these independent risk factors, a nine-point risk scoring model was created to firstly assess the postoperative parathyroid function status of patients and then to determine whether routine prophylactic calcium supplementation is needed. Importantly, the area under the curve (AUC) of the risk scoring model is equal to 0.979.ConclusionsAt present, prophylactic calcium supplementation after thyroid carcinoma surgery is a controversial postoperative treatment. It should be selectively implemented for high-risk patients with hypoparathyroidism after surgery. Routine prophylactic calcium supplementation is recommended for PTC patients with a score greater than or equal to 5, although there are no clinical symptoms of postoperative hypocalcemia caused by hypoparathyroidism. However, prophylactic calcium supplementation is not recommended for patients with PTC with a score of less than 5; if the patient develops hypocalcemia at the later stage, therapeutic calcium supplementation can then be implemented.

Project description:ImportanceBecause inadvertent damage of parathyroid glands can lead to postoperative hypocalcemia, their identification and preservation, which can be challenging, are pivotal during total thyroidectomy.ObjectiveTo determine if intraoperative imaging systems using near-infrared autofluorescence (NIRAF) light to identify parathyroid glands could improve parathyroid preservation and reduce postoperative hypocalcemia.Design, setting, and participantsThis randomized clinical trial was conducted from September 2016 to October 2018, with a 6-month follow-up at 3 referral hospitals in France. Adult patients who met eligibility criteria and underwent total thyroidectomy were randomized. The exclusion criteria were preexisting parathyroid diseases.InterventionsUse of intraoperative NIRAF imaging system during total thyroidectomy.Main outcomes and measuresThe primary outcome was the rate of postoperative hypocalcemia (a corrected calcium <8.0 mg/dL [to convert to mmol/L, multiply by 0.25] at postoperative day 1 or 2). The main secondary outcomes were the rates of parathyroid gland autotransplantation and inadvertent parathyroid gland resection.ResultsA total of 245 of 529 eligible patients underwent randomization. Overall, 241 patients were analyzed for the primary outcome (mean [SD] age, 53.6 [13.6] years; 191 women [79.3%]): 121 who underwent NIRAF-assisted thyroidectomy and 120 who underwent conventional thyroidectomy (control group). The temporary postoperative hypocalcemia rate was 9.1% (11 of 121 patients) in the NIRAF group and 21.7% (26 of 120 patients) in the control group (between-group difference, 12.6% [95% CI, 5.0%-20.1%]; P = .007). There was no significant difference in permanent hypocalcemia rates (0% in the NIRAF group and 1.6% [2 of 120 patients] in the control group). Multivariate analyses accounting for center and surgeon heterogeneity and adjusting for confounders, found that use of NIRAF reduced the risk of hypocalcemia with an odds ratio of 0.35 (95% CI, 0.15-0.83; P = .02). Analysis of secondary outcomes showed that fewer patients experienced parathyroid autotransplantation in the NIRAF group than in the control group: respectively, 4 patients (3.3% [95% CI, 0.1%-6.6%) vs 16 patients (13.3% [95% CI, 7.3%-19.4%]; P = .009). The number of inadvertently resected parathyroid glands was significantly lower in the NIRAF group than in the control group: 3 patients (2.5% [95% CI, 0.0%-5.2%]) vs 14 patients (11.7% [95% CI, 5.9%-17.4%], respectively; P = .006).Conclusions and relevanceThe use of NIRAF for the identification of the parathyroid glands may help improve the early postoperative hypocalcemia rate significantly and increase parathyroid preservation after total thyroidectomy.Trial registrationClinicalTrials.gov Identifier: NCT02892253.

Project description:Contrast-free autofluorescence (AF) of the parathyroid glands (PTGs) and thyroid tissue occurs in the near-infrared (NIR) spectrum on excitation by light in the upper range of the visible spectrum or lower NIR spectrum. In vivo, PTGs autofluoresce more brightly than thyroid (by a factor of 2-20 times) and appear as a bright spot against surrounding thyroid, muscle or fat on a processed image which is generated in real-time. NIR-AF of PTGs was first described in 2009 although NIR-AF had previously been used in several other clinical applications. Since then there has been a great amount of interest in the use of NIR-AF in thyroid and parathyroid surgery with over 25 published reports of the utilisation of both self-built and proprietary NIR-AF devices in neck endocrine surgery. All of these reports have confirmed the feasibility of NIR-AF intraoperatively and its ability to detect PTGs, although the reported accuracy varies from 90-100%. Reports of the effect of NIR-AF on relevant clinical endpoints i.e., post-operative hypoparathyroidism in thyroidectomy and persistent disease in parathyroidectomy are however scant. There has been one multicentre clinical trial of NIR-AF in thyroidectomy but this did not report clinical outcomes and two single-centre, non-randomised studies which did report post-operative hypoparathyroidism but with differing results: one showing no benefit in 106 NIR-AF vs. 163 controls and one, a reduction of early hypocalcaemia from 20% to 5% in 93 NIR-AF patients vs. 420 controls. There were only 2 cases of permanent hypoparathyroidism across both studies and therefore no significant observable difference in this key outcome variable. In parathyroidectomy, possible variability of the AF signal due to composition of a PTG adenoma, secondary/tertiary disease and MEN1 as well as depth-penetration preventing detection of sub-surface PTGs would imply that NIR-AF in its current form is not well-placed to improve cure-rates in hyperparathyroidism, which may already be as high as 98%. Thus far, no study has addressed this. Despite the promising results of NIR-AF, the absence of data demonstrating an improvement in outcomes and the cost of its use currently limit its use in routine clinical practice, especially in a publicly funded healthcare system with budgetary constraints. However, it can be utilised in research settings and this should be undertaken within the context of well-designed and conducted randomised, multi-centre, appropriately powered studies, which will assist in establishing its role in neck endocrine surgery.

Project description:IntroductionPostsurgical hypoparathyroidism (PoSH) is an iatrogenic condition that occurs as a complication of several different procedures with thyroid surgery being the most common. PoSH has significant short- and long-term morbidities. The volume of thyroid surgery is increasing, and PoSH is therefore likely to increase. Some studies have shown promising results using near-infrared fluorescence (NIRF) imaging in reducing the risk of PoSH which has the potential to significantly reduce morbidity and costs associated with monitoring and treatment.Methods and analysisNIFTy is an unblinded, parallel group, multicentre, seamless phase II/III randomised controlled trial in patients undergoing total or completion thyroidectomy. The trial incorporates a process evaluation (IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up framework) 2a) to inform the trial protocol, a phase II (IDEAL 2b) analysis using a surrogate primary outcome of 1 day transient hypocalcaemia to determine early futility and phase III (IDEAL 3) assessment of the primary outcome of PoSH at 6 months after surgery. 454 participants will be randomised on a 1:1 basis to evaluate thyroid surgery with NIRF and indocyanine green against standard thyroid surgery in reducing PoSH at 6 months after surgery, with the phase II analysis occurring once data are available for 200 participants. Analysis in both phases will be using multilevel logistic regression incorporating random effects with respect to surgeon and adjusting for minimisation factors. Phase III secondary outcomes include protracted hypoparathyroidism, hypercalcaemia, complications, length of stay, readmissions and patient reported quality of life using the Short Form 36 Health Survey Questionnaire and Hypoparathyroid Patient Questionnaire instruments.Ethics and disseminationNIFTy is funded by National Institute for Health and Care Research Efficacy and Mechanism Evaluation Programme (Grant Ref: 17/11/27) and approved by a Research Ethics Committee (reference: 21/WA/0375) and Health Research Authority (HRA). Trial results will be disseminated through conference presentations, peer-reviewed publication and through relevant patient groups.Trial registration numberISRCTN59074092.

Dataset Information

Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism: a randomized clinical trial.

Purpose

Method

Results

Conclusion

Trial registry

Publications

Effect of near infrared autofluorescence guided total thyroidectomy on postoperative hypoparathyroidism: a randomized clinical trial.

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