Liver stiffness assessed by real-time two-dimensional shear wave elastography predicts hypersplenism in patients with Wilson's disease: a prospective study.

BACKGROUND: The current study aimed to explore the value of liver stiffness assessed by two-dimensional real-time shear wave elastography (2D-SWE) to predict hypersplenism occurrence in Wilson's disease (WD) patients. METHODS: Ninety WD patients were enrolled in this prospective study between May 2018 and December 2018. Baseline clinical data and ultrasound imaging including 2D-SWE liver stiffness of WD patients were collected. After enrollment, patients had follow-ups for 24 months or until they developed hypersplenism. The hypersplenism risk factors were determined using Cox regressions and receiver operating characteristic curves (ROC). RESULTS: Twenty-nine (32.2%) patients developed hypersplenism. Age, portal vein diameter, and liver stiffness were independent hypersplenism risk factors in WD patients. The cutoff value of liver stiffness to predict hypersplenism was 10.45 kPa, with sensitivity and specificity of 75.9% and 73.8%, respectively. Patients were divided into two groups according to liver stiffness: ≥ 10.45 kPa (57.9% with hypersplenism) or < 10.45 kPa (13.5% with hypersplenism). The median time between enrollment and hypersplenism development was 15 months vs. 22 months (p < 0.001) for the two groups, respectively. CONCLUSION: The measurement of liver stiffness by 2D-SWE can be a reliable hypersplenism predictor in WD patients. Therefore, dynamic monitoring of WD patients using 2D-SWE is crucial for the early diagnosis of hypersplenism.

The Value of Thyroid Ultrasound Computer-Aided Diagnosis System in the Evaluation of Thyroid Nodules With Concurrent Hashimoto's Thyroiditis.

OBJECTIVE: To investigate the value of computer-aided diagnosis (CAD) system in assessing thyroid nodules concurrent with Hashimoto's thyroiditis (HT). METHODS: Totally 148 patients with 193 thyroid nodules were enrolled. A radiologist assessed the nodules using a thyroid ultrasound CAD system. Additionally, the nodules were evaluated by one experienced radiologist alone, and one training radiologist without and with CAD assistance. The diagnostic performance was compared between the CAD system and the experienced radiologist, and the training radiologist without and with CAD assistance. RESULTS: The CAD system demonstrated a similar sensitivity to that of the experienced radiologist in diagnosing thyroid cancers (89.8% versus 92.4%, P > .05). The specificity and accuracy of the CAD system were lower than that of the experienced radiologist in assessing the nodules with diffusedly altered glands (specificity, 60.0% versus 81.7%, P = .007; accuracy, 77.5% versus 88.1%, P = .011). With CAD assistance, the training radiologist had improved sensitivity and accuracy that increased to 87.9% and 86.8% in classifying nodules with sonographically evident HT (both P = .012). CONCLUSION: The CAD system has comparable sensitivity, but lower specificity compared with the experienced radiologist in diagnosing thyroid malignancies concurrent with HT. For a radiologist with less experience, the CAD system can help improve the diagnostic performance by increasing sensitivity and accuracy in assessing thyroid nodules with diffusely altered parenchyma.

Ultrasound Surveillance of Abnormal Cervical Lymph Nodes in Patients With Papillary Thyroid Carcinoma After Surgery.

OBJECTIVES: To document the changing trends of abnormal cervical lymph nodes (LNs) in patients with papillary thyroid carcinoma (PTC) who had serial follow-up ultrasound (US) scans after surgery and to determine how these node abnormalities progress in real time. METHODS: Ultrasound findings from 568 consecutive patients with PTC who were monitored postoperatively were reviewed. Abnormal LNs were classified as either suspicious or indeterminate according to the European Thyroid Association guidelines. Outcomes from US monitoring of the LNs were recorded and analyzed. RESULTS: Seventy-six (13.4%) of 568 patients were identified with abnormal LNs. Among them, 55 (72.4%) were initially found to have suspicious LNs, and the other 21 (27.6%) had indeterminate lesions. Of the 55 suspicious LNs, final scans showed that 38 (69.1%) lesions were still suspicious, whereas the remaining 17 (30.9%) nodes were shown to have resolved after a median follow-up of 36 months. Of the 21 indeterminate node abnormalities, final scans showed that 16 (76.2%) LNs remained indeterminate, whereas the other 5 (23.8%) nodes had developed into suspicious LNs after a median follow-up of 44 months. Loss of the fatty hilum and peripheral or diffusedly increased vascularity were more likely to be linked to persistent suspicious LNs (P = .02 and .04, respectively). Suspicious LNs with echogenic foci but a lack of other abnormal features were more frequently found to have resolved thereafter (P = .03). CONCLUSIONS: Abnormal LNs detected after PTC surgery can often remain indolent during US surveillance, and a small portion of the nodes would have resolved over time.

Study of the Ultrasound Appearance of the Normal Parathyroid Using an Intraoperative Procedure.

OBJECTIVES: This study was designed to confirm the echogenicity of normal parathyroid glands using intraoperative ultrasound (US). METHODS: Between October 2015 and January 2016, normal parathyroid glands were examined with an intraoperative US transducer during thyroidectomy procedures in 13 patients with thyroid disease. According to the findings from intraoperative US, routine percutaneous US of normal parathyroid glands was performed in a group of adults. On the basis of previous information on normal parathyroid echogenicity, a series of parathyroid diseases that were proved by surgery and histopathologic analyses were retrospectively reviewed. The presence of residual normal parathyroid in the lesion on US imaging, which was defined as the residual parathyroid sign in this study, was reviewed and correlated with histopathologic results. RESULTS: In the intraoperative US group, 23 parathyroid glands were scanned intraoperatively, and 21 (91.3%) were hyperechoic, homogeneous in texture, and oval. In the routine percutaneous US group, 106 parathyroid glands were found in total, and 96 (90.5%) of the glands had hyperechoic and homogeneous echogenicity, with 75 (70.8%) being oval. In the review of parathyroid diseases, 33 parathyroid glands in 30 cases were reviewed, with a positive residual parathyroid sign in 7 (21.2%) parathyroid glands, presenting with a hyperechoic rim in the margin, and 4 of them (12.1%) were confirmed by histopathologic results. CONCLUSIONS: The normal parathyroid had hyperechoic echogenicity on both intraoperative and percutaneous US imaging. Residual tissue of parathyroid glands can also be observed in some parathyroid abnormalities with an echogenic appearance on US imaging and confirmed by histopathologic results.

Lung Cancer Deaths in the National Lung Screening Trial Attributed to Nonsolid Nodules.

Purpose To validate the recommendation of performing annual follow-up of nonsolid nodules (NSNs) identified by computed tomographic (CT) screening for lung cancer, all cases of lung cancer manifesting as NSN in the National Lung Screening Trial (NLST) were reviewed. Materials and Methods Institutional review board and informed consent were waived for this study. The NLST database was searched to identify all participants with at least one NSN on CT scan with lung cancer as the cause of death (COD) documented by the NLST endpoint verification process. Among the 26 722 participants, 2534 (9.4%) had one or more NSNs, and lung cancer as the COD occurred for 48 participants. On review, 21 of the 48 patients had no NSN in the cancerous lobe, which left 27 patients whose CT scans were reviewed by four radiologists: Group A (n = 12) were cases of lung cancer as the COD because of adenocarcinoma, and group B (n = 15) were cases of lung cancer as the COD because of other cell types. Frequency of lung cancer as the COD because of NSN and the time from randomization to diagnosis within these groups was determined. Results Six of the 12 patients in group A had no NSN in the cancerous lobe whereas the remaining six patients had a dominant solid or part-solid nodule in the lobe that rapidly grew in four patients, was multifocal in one patient, and had a growing NSN in one patient in whom diagnosis was delayed for over 3 years. Five of the 15 patients in group B had no NSN, and for the remaining 10 patients, lung cancer as the COD was not because of NSN. Conclusion It seems unlikely that patients with lung cancer as the COD occurred with solitary or dominant NSN as long as annual follow-up was performed. This lends further support that lung cancers that manifest as NSNs have an indolent course and can be managed with annual follow-up. © RSNA, 2016.

CT screening for lung cancer: Frequency of enlarged adrenal glands identified in baseline and annual repeat rounds.

OBJECTIVES: To determine the frequency of adrenal enlargement of participants in a CT-screening program for lung cancer and demonstrate the progression during follow-up, separately for baseline and annual repeat rounds. MATERIALS AND METHODS: HIPAA-compliant informed consent was obtained in 4,776 participants. The adrenal gland was defined as enlarged if it measured ≥6 mm at its largest diameter. Logistic regression analyses were performed. RESULTS: At baseline, 202 (4 %) of 4,776 participants had adrenal enlargement. Significant factors were age (OR = 1.4, 95 % CI: 1.2-1.7) and current smoker (OR = 1.8, 95 % CI: 1.3-2.4). Follow-up 7-18 months after baseline for 133 cases with adrenal enlargement <40 mm showed it decreased or was stable in 85 (64 %), and increased by <10 mm in 48 (36 %). Five (0.04 %) cases of adrenal enlargement were newly identified, none increased beyond 40 mm on follow-up. Adrenal enlargement was a significant predictor of a subsequent diagnosis of lung cancer (OR = 2.0, 95 % CI: 1.2-3.4). CONCLUSION: Participants with adrenal enlargement <40 mm identified at baseline and on repeat screening could be reasonably assessed on subsequent annual screening. Adrenal enlargement increased with increasing pack-years of smoking. Adrenal enlargement was an independent predictor of a subsequent diagnosis of lung cancer. KEY POINTS: • Adrenal enlargement was seen in 4 % of participants at baseline screening. • Age and currently smoking were significantly associated with adrenal enlargement. • 0.04 % of participants were newly identified with adrenal enlargement. • Annual follow-up for adrenal enlargement <40 mm was appropriate. • Adrenal enlargement was an independent predictor of a diagnosis of lung cancer.

Combing superb microvascular imaging with shear wave elastography for risk stratification of Thyroid Imaging Reporting and Data System (TI-RADS) 4 thyroid nodules.

Background: It is difficult to accurately assess the risk of Thyroid Imaging Reporting and Data System (TI-RADS) 4 thyroid nodules due to the overlap of benign and malignant conventional ultrasound (US) features of nodules. To reduce unnecessary needle biopsies and assist clinical decision-making, this study established a dynamic nomogram incorporating superb microvascular imaging (SMI) and shear wave elastography (SWE) for the risk evaluation of TI-RADS 4 thyroid nodules. Methods: A total of 248 patients who underwent US, SMI, and SWE with cytological or histopathological results were included in this retrospective study, and were randomly divided into training (174 patients) and verification (74 patients) cohorts. The clinical characteristics and US, SMI, and SWE features of patients were analyzed in the training cohort. The least absolute shrinkage and selection operator (LASSO) regression and multivariate logistic regression were used to screen parameters and construct dynamic nomogram. The receiver operating characteristic (ROC) curves, calibration curve, and decision curve were used to evaluate the performance of the nomogram. Results: A dynamic nomogram was constructed based on age [odds ratio (OR) =0.954; P=0.005] , shape (OR =0.345; P=0.041), SMI (OR =9.511; P<0.001), and SWE (OR =3.670; P=0.001). The nomogram showed excellent discrimination both in the training [area under the curve (AUC): 0.848; 95% confidence interval (CI): 0.784-0.911] and validation (AUC: 0.862; 95% CI: 0.780-0.944) cohorts, and better than US, SMI, and SWE alone in all cohorts (P<0.05). The Nomo-score of each patient was calculated and the cut-off value was 0.607 which can be used to distinguish high-risk and low-risk patients. Conclusions: The SMI and SWE show added predictive value on risk stratification in patients with TI-RADS 4 thyroid nodules and a dynamic nomogram was constructed to screen high-risk individuals and assist the clinical decision-making.

Retraction notice to "The role of laryngeal ultrasound in diagnosis of infant laryngomalacia" [Int. J. Pediatr. Otorhinolaryngol. 124 (2019) 111-115].

This article has been retracted: please see Elsevier Policy on Article Withdrawal (https://www.elsevier.com/about/our-business/policies/article-withdrawal). This article has been retracted at the request of the Authors and the Editor-in-Chief. After a thorough investigation, the Editor-in-Chief has concluded that details in the origin of data and permissions integral to the article's acceptance in the journal necessitate a retraction. A single hospital was mentioned in the article but this was not where the data was collected. Reviewers would have assumed that informed consent was received and properly reviewed by this institution, as it was not otherwise specified. Several oversights within the article that were brought forward by the Authors make it clear that the article that was accepted had misrepresentation of key data. While the Authors presented some differences of opinion about how these concerns about the key data originated, it is clear that when the manuscript was accepted that Reviewers and Editors would not have had knowledge of these difficulties, and this may have created a different review process and outcome for this manuscript. One of the Authors has requested an ability to provide additional information to address the concerns. However, the Editor-in-Chief has decided that this would not follow the process for accepted manuscripts or address some of the concerns presented and, therefore, has settled on the retraction of the manuscript as the final decision regarding this paper.

Advancing medical device regulatory reforms for innovation, translation and industry development in China.

The blossoming Chinese medical device market calls for a science-based regulatory system in China. Consistent efforts have been made to advance the medical device regulatory reforms for innovation, translation and industry development. In this article, we report both the latest regulatory requirements which aim to ensure safety and efficacy for patients while encouraging innovation of the medical device industry, and the key programs on medical devices covered in the Regulatory Science Action Plan (RSAP) of the National Medical Products Administration of China (NMPA). The main features of the revised regulations are first elucidated before the opportunities for translational research are interpreted, including those for additive manufacturing and customized devices, drug-device combination products, artificial intelligence-powered software and surgical robots, and nanomaterials for medical devices. Finally, a regulatory perspective is provided to researchers who expect to translate their technologies in the Chinese medical device market. Important issues including early attention to critical market and clinical needs, understanding the true principle and spirit underlying the changing regulations and standards, and protecting intellectual property rights with comprehensive measures, are discussed. These developments warrant further investigations into the distinct role of regulatory science in shaping medical devices research and development.

Added benefits of early detection of other diseases on low-dose CT screening.

Low-dose CT screening for lung cancer provides images of the entire chest and upper abdomen. While the focus of screening is on finding early lung cancer, radiology leadership has embraced the fact that the information contained in the images presents a new challenge to the radiology profession. Other findings in the chest and upper abdomen were not the reason for obtaining the screening CT scan, nor symptom-prompted, but still need to be reported. Reporting these findings and making recommendations for further workup requires careful consideration to avoid unnecessary workup or interventions while still maximizing the benefit that early identification of these other diseases provided. Other potential findings, such as cardiovascular disease and chronic pulmonary obstructive diseases actually cause more deaths than lung cancer. Existing recommendations for workup of abnormal CT findings are based on symptom-prompted indications for imaging. These recommendations may be different when the abnormalities are identified in asymptomatic people undergoing CT screening for lung cancer. I-ELCAP, a large prospectively collected multi-institutional and multi-national database of screenings, was used to analyze CT findings identified in screening for lung cancer. These analyses and recommendations were made by radiologists in collaboration with clinicians in different medical specialties.

The role of laryngeal ultrasound in diagnosis of infant laryngomalacia.

OBJECTIVE: The purpose of this study was to evaluate the role of laryngeal ultrasound in diagnosis of infant laryngomalacia. METHODS: Forty consecutive infant patients with inspiratory stridor or other laryngeal symptoms underwent flexible fiberoptic nasopharyngolaryngoscopy and laryngeal ultrasound examination from January 2014 to May 2014. The curling angle of the epiglottis and/or arytenoid tissue collapses on laryngeal ultrasound during inspiration were used to diagnose infant laryngomalacia. The value of laryngeal ultrasound in diagnosis of infant laryngomalacia was evaluated and further compared to that of flexible fiberoptic nasopharyngolaryngoscopy. RESULTS: The mean angle of the curling epiglottis in 26 patients with laryngomalacia was 69.1 ±â€¯8.1 degrees, while the mean angle of the slightly curling epiglottis in 12 patients without laryngomalacia was 89.6 ±â€¯9.7 degrees (p < 0.0001). Arytenoid tissue collapses were found in 24 patients with laryngomalacia and only one patient without laryngomalacia had a local collapse of arytenoid tissue (p < 0.0001). Twenty six of the 28 patients with laryngomalacia diagnosed by flexible fiberoptic nasopharyngolaryngoscopy were detected by laryngeal ultrasound. There was an excellent consistency between laryngeal ultrasound and flexible fiberoptic nasopharyngolaryngoscopy in the detection of infant laryngomalacia (κ = 0.826). Laryngeal ultrasound had a sensitivity of 96.3%, a specificity of 84.6%, a positive predictive value of 92.9%, and a negative predictive value of 91.7% in diagnosing infant laryngomalacia. CONCLUSIONS: Laryngeal ultrasound can help diagnose infant laryngomalacia through visualizing omega-shaped epiglottis and/or arytenoid tissue collapse during inspiration. The modality has an excellent consistency with flexible fiberoptic nasopharyngolaryngoscopy in diagnosis of the disease.

Precise Detection of Gene Mutations in Fine-Needle Aspiration Specimens of the Papillary Thyroid Microcarcinoma Using Next-Generation Sequencing.

PURPOSE: To assess the feasibility of next-generation sequencing (NGS) to detect mutations in BRAF, RAS, TERT promoter, and TP53 genes in ultrasound-guided fine-needle aspiration (FNA) biopsy samples of the papillary thyroid microcarcinoma (PTMC). METHODS: A total of 135 FNA samples out of 135 patients with suspected PTMC were submitted for mutation testing using NGS. NGS was successfully performed in 114 specimens, while the remaining 21 samples were excluded due to insufficient amount/poor quality of DNA and sequencing failure. Of those 114 samples, 72 who were confirmed as having PTMC by postoperative histopathology were enrolled in our study, and the other 42 who had a follow-up with ultrasound were excluded. Mutations of genes including BRAF, NRAS, HRAS, KRAS, TERT promoter, and TP53 were evaluated using NGS. The associations of gene mutations and clinicopathological characteristics of PTMC were analyzed. RESULTS: BRAF mutation was observed in 59 (81.94%) of 72 specimens. This mutation detected in BRAF was p.V600E (c.1799T>A) in exon 15 of all 59 specimens. NRAS mutation was identified in 1 (1.39%) specimen classified as Bethesda III and pathologically confirmed as a follicular variant PTMC. There were no mutations found in TERT promoter or TP53. The tumor with a maximum diameter (D max) larger than 5 mm was shown to be significantly correlated with the BRAF mutation in a multivariate analysis (OR 5.52, 95% CI 1.51-26.42, P = 0.033). But the BRAF mutation was not found to be significantly associated with the gender or age of patients with PTMC (P > 0.05). CONCLUSIONS: This study demonstrated that gene mutations in FNA specimens of PTMC could be successfully analyzed with a higher sensitivity using NGS compared to conventional methods for mutation detection. BRAF mutation of p.V600E was statistically associated with PTMC with a D max larger than 5 mm.

Sonography used in the infantile desmoid fibromatosis of postcricoid area: A case report.

RATIONALE: Infantile desmoid fibromatosis of the postcricoid area is a rare disease and is characterized by a proliferation of fibrous tissue with non-metastasis, local infiltration, and a high rate of recurrence after surgical resection. Currently, ultrasound is scarcely used in the hypopharynx and larynx area. PATIENT CONCERNS: A 4-year-old boy presented with hoarseness, deep voice and snoring for 2∼4 years without any surgical history. On sonography, the lesion was found in the postcricoid area, and the left larynx showed impaired mobility in real time observation. Complete excision with a negative margin in this pivotal anatomic area is impossible, and necessitates a long-time surveillance. DIAGNOSES: Infantile desmoid fibromatosis of the postcricoid area was diagnosed according to surgery and histopathology. INTERVENTIONS: Local excision was carried out to relieve the upper airway narrowing. OUTCOMES: Relieved hoarseness and snoring were reported on the latest follow-up. A residual lesion was seen in the surgical bed and maintained a stable extent on ultrasound and MR imaging after a year. LESSONS: Considering the non-radiation merit and diagnostic ability, ultrasonography is advocated as a valuable supplementary imaging method to CT, MR and laryngoscopy in the juvenile larynx and hypopharynx.