Cost-Utility Analysis of Early Detection with Ultrasonography of Differentiated Thyroid Cancer: A Retrospective Study on a Korean Population.

Background: There is debate about ultrasonography screening for thyroid cancer and its cost-effectiveness. This study aimed to evaluate the cost-effectiveness of early screening (ES) versus symptomatic detection (SD) for differentiated thyroid cancer (DTC) in Korea. Methods: A Markov decision analysis model was constructed to compare the cost-effectiveness of ES and SD. The model considered direct medical costs, health outcomes, and different diagnostic and treatment pathways. Input data were derived from literature and Korean population studies. Incremental cost-effectiveness ratio (ICER) was calculated. Willingness-to-pay (WTP) threshold was set at USD 100,000 or 20,000 per quality-adjusted life year (QALY) gained. Sensitivity analyses were conducted to address uncertainties of the model's variables. Results: In a base case scenario with 50 years of follow-up, ES was found to be cost-effective compared to SD, with an ICER of $2,852 per QALY. With WTP set at $100,000, in the case with follow-up less than 10 years, the SD was cost-effective. Sensitivity analysis showed that variables such as lobectomy probability, age, mortality, and utility scores significantly influenced the ICER. Despite variations in costs and other factors, all ICER values remained below the WTP threshold. Conclusion: Findings of this study indicate that ES is a cost-effective strategy for DTC screening in the Korean medical system. Early detection and subsequent lobectomy contribute to the cost-effectiveness of ES, while SD at an advanced stage makes ES more cost-effective. Expected follow-up duration should be considered to determine an optimal strategy for DTC screening.

The Effect of Thyroid Surgery on the Accuracy of Palpation-Based Cricothyroid Membrane Identification in Female Patients: A Prospective Observational Cohort Study.

Background and Objectives: This study examined how a history of thyroid surgery impacts the precision of cricothyroid membrane (CTM) identification through palpation (validated by ultrasound) in female patients visiting the operating room for surgeries unrelated to neck procedures. Materials and Methods: This prospective observational cohort study enrolled adult female patients undergoing elective non-neck surgery, dividing them into control (no thyroid surgery history; n = 40) and experimental (with thyroid surgery history; n = 40) groups. CTM identification was performed by palpation and confirmed via ultrasound. Results: There were no significant differences between two groups in the demographic characteristics of the patients. The success rate and accuracy of CTM identification through palpation were significantly higher in the control group compared to the experimental group (90% vs. 42.5%, respectively; p < 0.001). For female patients with a history of thyroid surgery, the sensitivity of successful CTM palpation was 42.5%, and the specificity was 10%. These figures are based on the calculated true positives (17), false positives (36), true negatives (4), and false negatives (23). Conclusions: Thyroid surgery history in female patients may hinder the accurate palpation-based identification of the CTM, suggesting a need for enhanced clinical practices and considerations during airway management training.

Cost-effectiveness of intraoperative neural monitoring of recurrent laryngeal nerves in thyroid lobectomy for papillary thyroid carcinoma.

Purpose: Recurrent laryngeal nerve injury after thyroid surgery may cause vocal cord palsy (VCP), which leads to unexpected additional costs. In recent years, intraoperative neural monitoring (IONM) has been used to lower the incidence rate of VCP. This study aimed to analyze postoperative management costs for patients with papillary thyroid carcinoma (PTC). Methods: We analyzed the medical records of patients who underwent lobectomy for PTC from September 2018 to August 2019 at The Catholic University of Korea, Seoul St. Mary's Hospital. A total of 411 patients were enrolled and all the patients had voice examinations. We investigated the total costs in the IONM and non-IONM groups during a maximum 1-year follow-up and calculated the additional costs due to VCP by subtraction of the mean values in each group. Results: The incidence rate of VCP was 3.9% (16 of 411). Extrathyroidal extension was related to VCP in Cox regression tests and accounted for 3.2% (13 of 411). VCP rate did not show a significant difference between the IONM and non-IONM groups (4.1% vs. 3.8%, P = 0.883). Total costs for postoperative management were higher in the IONM group than in the non-IONM group (US $328.2 ± $220.1 vs. $278.7 ± $141.4, P < 0.05). However, the additional costs due to VCP were significantly lower in the IONM group than in the non-IONM group ($474.1 ± $150.3 vs. $568.9 ± $367.6, P < 0.005). Conclusion: The use of IONM can mitigate the increase in costs by saving additional expenses associated with VCP.

Diagnostic utilities of washout CYFRA 21-1 combined with washout thyroglobulin for metastatic lymph nodes in thyroid cancer: a prospective study.

Cervical lymph node (LN) metastasis is common in differentiated thyroid cancer (DTC). This study evaluated the utility of the washout CYFRA 21-1 level, combined with the thyroglobulin (Tg) concentration, in terms of diagnosis of LN metastasis. We prospectively enrolled 53 patients who underwent thyroid surgery to treat DTC with lateral cervical LN metastases. Preoperative ultrasound guided needle localization was used to surgical sampling of specific LNs during the operation. The intraoperative washout Tg and CYFRA 21-1 levels were measured in such LNs. The Tg and CYFRA 21-1 levels differed significantly between metastatic and benign LNs. The cutoff values were 2.63 ng/mL for washout CYFRA 21-1 and 22.62 ng/mL for Tg. Combined use of the washout Tg and CYFRA 21-1 levels afforded the highest diagnostic accuracy (92.5%), better than that of individual markers. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) were 94.6%, 90.0%, 91.4%, 93.8%, respectively. The conjunction of the washout CYFRA21-1 and Tg levels enhances the diagnostic accuracy of LN metastasis in DTC patients. The washout CYFRA 21-1 level may be useful when malignancy is suspected, especially in cases where the cytology and washout Tg findings do not provide definitive results.

Re-do transoral robotic thyroidectomy is feasible: preliminary results of the surgical feasibility and efficacy of completion transoral robotic thyroidectomy - cohort study.

BACKGROUND: Transoral robotic thyroidectomy (TORT) has proven to be a safe and effective procedure with favorable surgical and cosmetic outcomes, but its application in completion thyroidectomy procedures remains to be established. In this study, we present our experience with completion TORT, assessing its surgical feasibility and efficacy. between February 2017 and August 2023. METHODS: We conducted a retrospective analysis of consecutive patients who underwent completion TORT after an initial TORT procedure between February 2017 and August 2023. RESULTS: A total of 10 patients (three males and seven females) were included in the study, with a mean age of 42.2±13.5 years. The indications for completion thyroidectomy included five cases of aggressive initial lesions and five cases of metachronous papillary thyroid carcinoma detected in the remnant lobe. The median interval between the initial and completion TORT procedures was 6.5 months. Flap dissection time showed no significant difference between the initial TORT and completion TORT operations (43.3±7.5 vs. 36.2±11.2, P=0.125). However, the mean console time (127.9±42.6 vs. 86.4±26.3 min, P=0.019) and mean total operation time (206.7±65.9 vs. 146.0±34.9 min, P=0.021) were significantly longer during the initial TORT procedure than during the completion TORT procedure. Two patients experienced transient hypoparathyroidism, which resolved within four weeks postoperatively. No other complications, such as vocal cord palsy, mental nerve injury, or bleeding, were observed. The median follow-up period was 21.5 months, and no recurrences were detected in any of the patients. CONCLUSIONS: Our study demonstrates that re-do TORT is feasible, showing excellent cosmetic results and minimal adverse effects. Completion TORT may be considered a viable option for selected patients who require completion thyroidectomy after an initial TORT procedure.

Safety and surgical outcomes of single-port trans-axillary robot-assisted thyroidectomy: Experience from a consecutive series of 300 patients.

Since the introduction of the single-port (SP) robotic system, SP trans-axillary robot-assisted thyroidectomy (SP-TART) has been performed. We aimed to evaluate the safety and surgical outcomes of SP-TART in a consecutive series of 300 cases. We analyzed 300 patients with thyroid disease who underwent SP-TART from October 2021 to May 2023 in St. Mary's Hospital in Seoul, Korea. We analyzed the patients' clinicopathological characteristics and perioperative outcomes according to surgical extent. Of the 300 cases analyzed, 250 patients underwent less than total thyroidectomy (LTT), 31 patients underwent total thyroidectomy (TT), and 19 patients underwent TT with modified radical neck dissection (TT c mRND). The mean operative times for LTT, TT, and for TT c mRND were 69.8 ± 23.6, 104.2 ± 30.7, and 223.7 ± 72.4 min, respectively. Complications, including postoperative bleeding, transient hypoparathyroidism, and vocal cord palsy, were observed in nine, six, and six LTT, TT, and TT c mRND cases. The SP-TART method is a safe and feasible surgical option with a short operative time, good surgical outcome, and excellent cosmetic results.

BRAFV600E Positivity-Dependent Effect of Age on Papillary Thyroid Cancer Recurrence Risk.

BRAFV600E positivity is associated with increased aggressiveness of papillary thyroid cancer (PTC), and age is an important prognostic factor. However, the association between age and BRAFV600E positivity and the recurrence risk has not been investigated. This study aimed to investigate the impact of age on recurrence between patients with BRAFV600E-positive and -negative PTC. Patients with PTC who underwent initial thyroid surgery between January 2010 and December 2018 at Seoul St. Mary's Hospital (Seoul, Republic of Korea) were retrospectively reviewed. The BRAFV600E-positive (n = 1768) and BRAFV600E-negative groups (n = 428) were divided into two subgroups: younger (<35 years) and older groups (≥55 years). In the BRAFV600E-positive group, the younger group exhibited higher lymphatic and vascular invasion rates, more positive lymph nodes, higher lymph node ratios, and higher recurrence rates than the older group (5.9% vs. 2.1%). Multivariate analysis revealed that age, lymphatic invasion, and N category were significant risk factors in the BRAFV600E-positive group. In the BRAFV600E-positive group, the younger group had a higher recurrence risk than the older group (OR, 2.528; 95% confidence interval, 1.443-4.430; p = 0.001). In the BRAFV600E-negative group, age had no impact on recurrence risk. These results contribute to tailored treatment strategies and informed patient management.

Identification of NIFTP-Specific mRNA Markers for Reliable Molecular Diagnosis of Thyroid Tumors.

Non-invasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) is a low-risk thyroid tumor with a favorable prognosis. Nonetheless, differentiating NIFTP from other thyroid tumors remains challenging, necessitating reliable diagnostic markers. This study is aimed at discovering NIFTP-specific mRNA markers through RNA sequencing analysis of thyroid tumor tissues. We performed mRNA expression profiling for 74 fresh frozen thyroid tissue samples, including NIFTP and benign and malignant follicular-cell-derived tumors. NIFTP/malignant tumors showed 255 downregulated genes and 737 upregulated genes compared to benign tumors. Venn diagram analysis revealed 19 significantly upregulated and 7 downregulated mRNAs in NIFTP. Akaike information criterion analysis allowed us to select OCLN, ZNF423, LYG1, and AQP5 mRNA markers. We subsequently developed a predictive model based on logistic regression analysis using these four mRNAs, which we validated in independent samples (n = 90) using a qRT-PCR assay. This model demonstrated high accuracy in predicting NIFTP in discovery dataset (AUC (area under the receiver operating characteristic) = 0.960) and the validation dataset (AUC = 0.757). Our results suggest that OCLN, ZNF423, LYG1, and AQP5 mRNA markers might serve as reliable molecular markers for identifying NIFTP among other thyroid tumors, ultimately aiding in accurate diagnosis and management of NIFTP patients.

Cost-Effectiveness of Active Surveillance Compared to Early Surgery of Small Papillary Thyroid Cancer: A Retrospective Study on a Korean Population.

BACKGROUND: Recently, active surveillance (AS) has been introduced as an alternative to early surgery (ES) for the management of papillary thyroid microcarcinoma (PTMC), because of its indolent features and low mortality. However, its cost effects have not been determined and the findings of current studies differ, according to each country's medical system. METHODS: A Markov model was constructed to compare the cost-effectiveness of AS and ES, based on a reference case of a 40-year-old patient diagnosed with PTMC. Costs and transition probabilities were derived from previous clinical studies in Korean populations, and the incremental cost-effectiveness ratio (ICER) and net monetary benefit (NMB) were calculated. The willingness-to-pay (WTP) threshold was set at USD 100,000 per quality-adjusted life year (QALY) gained. Sensitivity analyses were conducted to address the uncertainties in the model's variables. RESULTS: From the base scenario, the cumulative costs and effectiveness were both higher in ES than AS. The ICER for ES, compared with AS, was USD 6,619.86/QALY, lower than the set WTP. The NMB difference between AS and ES increased across the stages (USD 5,980 at the first stage and USD 159,667 at the last stage). The ICER increased along with decreasing age and increasing cost of surgery. The higher the ES utility score and the lower that of AS, the more cost-effective ES, with WTP set at USD 30,000. CONCLUSION: In the current Korean medical system, ES is more cost-effective than AS. ES is more cost-effective as it is diagnosed at young age and followed-up for a long time.

Clinical Implication of Bilateral and Unilateral Multifocality in Papillary Thyroid Carcinoma: A Propensity Score-Matched Study.

Papillary thyroid cancer (PTC) is commonly characterized by multifocality, which is associated with aggressive features and a less favorable prognosis. The current study aimed to compare the clinicopathologic characteristics and long-term oncological outcomes of bilateral and unilateral multifocal PTC. The medical records of 1745 patients with multifocal PTC who underwent thyroid surgery at Seoul St. Mary's Hospital were retrospectively reviewed. The clinicopathological characteristics and recurrence rates were compared based on cancer laterality. Further, 357 patients who underwent total thyroidectomy were matched to investigate the recurrence risk and disease-free survival (DFS). Before propensity score matching (PSM), there was no significant difference in the recurrence rate between the bilateral and unilateral multifocal PTC groups. Cancer laterality was not a predictor of DFS based on the Cox regression analyses. However, after PSM, unilateral multifocality was associated with a significantly high risk of recurrence. Similarly, unilateral multifocality was associated with a significantly poor DFS based on the Kaplan-Meier analysis. Compared with bilateral PTC, unilateral multifocal PTC was associated with a poor DFS. A comprehensive preoperative examination should be performed to detect multifocality before the initial surgical intervention for optimal treatment. Postoperative short-term follow-up is recommended for unilateral multifocal PTC for recurrence surveillance.

Mouse Models to Examine Differentiated Thyroid Cancer Pathogenesis: Recent Updates.

Although the overall prognosis of differentiated thyroid cancer (DTC), the most common endocrine malignancy, is favorable, a subset of patients exhibits aggressive features. Therefore, preclinical models that can be utilized to investigate DTC pathogenesis and novel treatments are necessary. Various mouse models have been developed based on advances in thyroid cancer genetics. This review focuses on recent progress in mouse models that have been developed to elucidate the molecular pathogenesis of DTC.

Lymph Node Ratio Predicts Recurrence in Patients with Papillary Thyroid Carcinoma with Low Lymph Node Yield.

The American Thyroid Association risk stratification system suggests that having >5 metastatic lymph nodes (LNs) increase the recurrence risk in patients with papillary thyroid carcinoma (PTC). However, little is known about PTC with <5 harvested LNs. This study aimed to stratify patients with low-LN-yield (low-LNY) PTC based on lymph node ratios (LNRs). From 2007 to 2017, 6317 patients who underwent thyroidectomies were diagnosed with PTC at Seoul St. Mary's Hospital, and 909 patients with low LNYs were included in the study. Tumor recurrence was compared based on LNR. The LNR cutoff was determined using a receiver operating characteristic curve. Forty-six patients (5.1%) experienced recurrences over a mean follow-up period of 127.24 ± 33.6 months (range, 5-190 months). The cutoff for the low-LNR (n = 675) and high-LNR (n = 234) groups was 0.29 (AUC = 0.676, 95% CI = 0.591-0.761, p < 0.001). The recurrence rate was significantly higher in the high-LNR group compared to the rate in the low-LNR group (12.4% vs. 2.5%, p < 0.001). Multivariate analysis using Cox regression revealed that tumor size and LNR ≥ 0.29 were independent prognostic factors for recurrence. Therefore, LNR can be utilized to stratify the risk of recurrence in patients with low-LNY PTC.

Persistent subjective voice symptoms for two years after thyroidectomy.

BACKGROUND: Voice change after thyroidectomy is an important issue in thyroid surgery. However, little is known about long-term voice outcomes after thyroidectomy. This study investigates the long-term voice outcomes of thyroidectomy up to two years after surgery. Also, we analyzed the pattern of recovery through acoustic tests over time. METHODS: We reviewed data from 168 patients who underwent thyroidectomy between January 2020 and August 2020 at a single institution. The Thyroidectomy-related Voice and Symptom Questionnaire (TVSQ) score and acoustic voice analysis results were examined preoperatively and postoperative one, three, and six months, and one and two years after surgery. We divided patients into two groups based on the TVSQ score (≥15 or <15) at two years postoperatively. We investigated the difference of acoustic characteristics between the two groups and analyzed correlations between acoustic parameters and various clinical and surgical factors. RESULTS: Voice parameters tended to recover, but some parameters and TVSQ scores exhibited deterioration two years after surgery. In the subgroups, among the many clinicopathologic factors examined, voice abuse history including professional voice users (p = 0.014), greater extent of thyroidectomy and neck dissection (p = 0.019, p = 0.029), and high pitch voice (F0; p = 0.005, SFF; p = 0.016) were associated with high TVSQ score at two years. CONCLUSIONS: Patients frequently experience voice discomfort after thyroidectomy. After surgery, voice abuse history including professional voice users, greater extent of surgery, and higher pitch voice are associated with worse voice quality and increased risk of persistent voice symptoms over the long-term.

Clinical Significance of the Lymph Node Ratio of the Second Operation to Predict Re-Recurrence in Thyroid Carcinoma.

The purpose of this study was to establish the risk factors for re-recurrences and disease-specific mortality (DSM) in recurrent thyroid cancer. Patients with recurrent thyroid cancer who underwent initial thyroid surgery from January 2000 to December 2019 at Seoul St. Mary's Hospital (Seoul, Korea) were assessed. Clinicopathological characteristics and long-term oncologic outcomes were compared between patients with one recurrence (n = 202) and patients with re-recurrences (n = 44). Logistic regression and cox-regression analyses were conducted to determine the risk factors for re-recurrences and DSM, respectively. Receiver-operating characteristic curve analysis was performed to determine the cutoff value for lymph node ratio (LNR) as a predictor of re-recurrences. DSM was significantly higher in the re-recurrence group compared with the single-recurrence group (6.8% vs. 0.5%, p = 0.019). Surgical treatment at the first recurrence significantly lowered the risk of re-recurrences. Age (≥55), male sex, and LNR (≥0.15) were independent significant risk factors for re-recurrences in patients who underwent surgery at the first recurrence. Surgical resection is the optimal treatment for initial thyroid cancer recurrence. LNR at re-operation is more effective in predicting re-recurrence than the absolute number of metastatic LNs.

Theranostics for Triple-Negative Breast Cancer.

Triple-negative breast cancer (TNBC) is an aggressive subtype of breast cancer with poor prognosis. Current endocrine therapy or anti HER-2 therapy is not available for these patients. Chemotherapeutic treatment response varies among patients due to the disease heterogeneity. To overcome these challenges, theranostics for treating TNBC have been widely investigated. Anticancer material conjugated nanoparticles with target-binding ligand and tracer agents enable simultaneous drug delivery and visualization of the lesion with minimal off-target toxicity. In this review, we summarize recently FDA-approved targeted therapies for TNBC, such as poly-ADP-ribose polymerase (PARP) inhibitors, check point inhibitors, and antibody-drug conjugates. Particularly, novel theranostic approaches including lipid-based, polymer-based, and carbon-based nanocarriers are discussed, which can provide basic overview of nano-therapeutic modalities in TNBC diagnosis and treatment.

Investigation of optimal convolutional neural network conditions for thyroid ultrasound image analysis.

Neural network models have been used to analyze thyroid ultrasound (US) images and stratify malignancy risk of the thyroid nodules. We investigated the optimal neural network condition for thyroid US image analysis. We compared scratch and transfer learning models, performed stress tests in 10% increments, and compared the performance of three threshold values. All validation results indicated superiority of the transfer learning model over the scratch model. Stress test indicated that training the algorithm using 3902 images (70%) resulted in a performance which was similar to the full dataset (5575). Threshold 0.3 yielded high sensitivity (1% false negative) and low specificity (72% false positive), while 0.7 gave low sensitivity (22% false negative) and high specificity (23% false positive). Here we showed that transfer learning was more effective than scratch learning in terms of area under curve, sensitivity, specificity and negative/positive predictive value, that about 3900 images were minimally required to demonstrate an acceptable performance, and that algorithm performance can be customized according to the population characteristics by adjusting threshold value.

The learning curve for single-port transaxillary robotic thyroidectomy (SP-TART): experience through initial 50 cases of lobectomy.

The new da Vinci® single-port (SP) robotic system, which utilizes a smaller incision and work space compared to the previous versions, is suitable for thyroidectomy. This study aimed to evaluate the learning curve for SP transaxillary robotic thyroidectomy (SP-TART) in a single-center. Fifty consecutive patients who underwent SP-TART between October 2021 and April 2022 in Seoul St. Mary's Hospital in Seoul, Korea, were included in this retrospective analysis. We examined the clinicopathological characteristics and short-term surgical outcomes and assessed the learning curve for SP-TART using cumulative summation analysis. The mean operation time was 57.8 ± 14.1 min, and the mean tumor size was 1.0 ± 0.7 (range, 0.3-3.7) cm. The patients were discharged approximately 2 days after surgery, and only two (4%) patients developed postoperative complications, including drainage-site bleeding and surgical site infection. Risk factors for long operation time were thyroiditis, amount of blood loss, and lymph node metastasis. The learning curve for SP-TART was 20 cases for the experienced robotic surgeon. SP-TART is technically feasible and safe with a short incision length and short operation time. It is a valuable alternative operative option with good surgical outcomes and outstanding cosmetic results.

Safety and Feasibility of Single-Port Trans-Axillary Robotic Thyroidectomy: Experience through Consecutive 100 Cases.

Background and Objectives: Recently, the single-port (SP) robotic system was introduced for minimally invasive operative techniques. Thus, this study aimed to validate the safety and feasibility of SP trans-axillary robotic thyroidectomy (SP-TART) through experiences in a single tertiary institution. Materials and Methods: This study retrospectively analyzed 100 consecutive patients who underwent SP-TART from October 2021 to June 2022 in Seoul St. Mary's Hospital in Seoul, Korea. We analyzed the clinicopathological characteristics and perioperative outcomes, including complications. Results: Less than total thyroidectomy (LTT) was performed in 81, total thyroidectomy (TT) in 16, and TT with modified radical neck dissection (mRND) in 3 patients. The mean operation time (min) was 53.3 ± 13.7, 86.3 ± 15.1, and 245.7 ± 36.7 in LTT, TT, and TT with mRND, respectively. The mean postoperative hospital stay was 2.0 ± 0.2, 2.1 ± 0.3, and 3.7 ± 1.5 days, respectively. A total of 84 cases of thyroid cancer were included, and 97.6% of them (82 cases) were papillary carcinoma and the rest were follicular and poorly differentiated carcinomas. Regarding complications, five cases had major complications, including three cases of vocal cord palsy and two cases of transient hypoparathyroidism. Conclusions: SP-TART is safe and feasible with a short operation time and a short length of hospital stay.

Clinical Significance of Tumor Size in Gross Extrathyroidal Extension to Strap Muscles (T3b) in Papillary Thyroid Carcinoma: Comparison with T2.

The purpose of the present study was to compare the risk of recurrence between T2 and T3b papillary thyroid carcinoma (PTC) and the effect of tumor size on survival in T3b disease. A total of 634 patients with PTC who underwent thyroid surgery at a single center were retrospectively analyzed. Clinicopathological characteristics were compared according to the T category in the TNM staging system, with T3b divided into T3b-1 (tumor size, ≤2 cm) and T3b-2 (tumor size, 2-4 cm). Disease-free survival (DFS) and recurrence risk were compared between T2, T3b, T3b-1, and T3b-2. Tumor size was significantly larger in T2 than in T3b. A significant difference in recurrence was observed between T2 and T3b-2 but not between T2 and T3b-1. T3b-2 was identified as a significant risk factor for PTC recurrence. A significant difference in the DFS curve was observed between T2 and T3b-2. However, no significant differences in survival were observed between T2 and T3b or T3b-1. These results indicate that the prognostic impact of T3b may vary depending on tumor size. Further studies are required to determine the need for T classifications that account for tumor size and gETE invasion of the strap muscles.

Efficacy and safety of temperature-sensitive acellular dermal matrix in prevention of postoperative adhesion after thyroidectomy: A randomized, multicenter, double-blind, non-inferiority study.

INTRODUCTION: MegaShield® is a newly developed temperature-sensitive anti-adhesive containing micronized acellular dermal matrix. The aim of this study was to investigate the efficacy and safety of MegaShield® compared with Guardix-SG® in the prevention of adhesions in patients undergoing bilateral total thyroidectomy. METHOD: We conducted a multicenter trial between October 2018 and March 2020 in patients undergoing total thyroidectomy. The patients were randomly assigned to either the MegaShield® group or the Guardix-SG® group. The primary outcome was the esophageal movement using marshmallow six weeks after the surgery and the secondary outcome was the assessed adhesion score. The safety assessment was also evaluated. RESULTS: The study included 70 patients each in the MegaShield® and control (Guardix-SG®) groups. Baseline clinical characteristics, the mean score of marshmallow esophagography, and the sum of adhesion scores were not statistically different between the two groups. Inferiority test demonstrated that the efficacy of MegaShield® is not inferior to that of Guardix-SG®. There were no device-related complications in both groups. CONCLUSION: The efficacy and safety of MegaShield® were not inferior than those of Guardix-SG®. MegaShield® demonstrated the potential of ADM as a potential future anti-adhesive agent. TRIAL REGISTRATION: The name of trial registry CRIS (Clinical Research Information Service) https://cris.nih.go.kr/cris/index.jsp. (The full trial protocol can be accessed) Registration number: KCT0003204.