OBJECTIVE: The aim of this study is to test the accuracy of the AW frame by a direct head to head comparison with CRW® frame (Integra Life Sciences, Plainsboro, NJ) on a phantom.
METHODS: This is a prospective pilot cross-sectional phantom study with a total of 42 (21 for AW and 21 for CRW®) laboratory testings performed in 2017 at our institute to compare the accuracies of both frames in a consecutive manner. A phantom (BL phantom) was newly created, where targets can be placed at different heights and positions on a platform attached under the frame for accuracy testing comparing between the AW and CRW® frames.
RESULTS: A comparable accuracy testing results were observed between the AW and CRW® frames of 0.64 mm versus 1.07 mm respectively. Approval from the local ethics committee for a clinical trial was obtained. We report on three case illustrations who had the AW frame-based biopsies with definitive diagnoses and without any post-biopsy related complication.
CONCLUSION: AW frame successfully demonstrated a good accuracy of 0.64 mm in phantom testing using the BL phantom by a linear algorithmic calculation. The clinical trial with three patients demonstrated definitive diagnoses and safety with its use.
METHODS: This international study included seven adult cohorts with suspected NAFLD who underwent liver biopsy, LSM and blood sampling during routine clinical practice or screening for trials. The population was randomly divided into a training set and an internal validation set, on which the best-fitting logistic regression model was built, and performance and goodness of fit were assessed, respectively. Furthermore, both scores were externally validated on two large cohorts. Cut-offs for high sensitivity and specificity were derived in the training set to rule-out and rule-in cirrhosis or AF and then tested in the validation set and compared to FIB-4 and LSM.
RESULTS: Each score combined LSM, AST/ALT ratio, platelets, sex and diabetes status, as well as age for Agile 3+. Calibration plots for Agile 4 and Agile 3+ indicated satisfactory to excellent goodness of fit. Agile 4 and Agile 3+ outperformed FIB-4 and LSM in terms of AUROC, percentage of patients with indeterminate results and positive predictive value to rule-in cirrhosis or AF.
CONCLUSIONS: The two novel non-invasive scores improve identification of cirrhosis or AF among individuals with NAFLD attending liver clinics and reduce the need for liver biopsy in this population.
IMPACT AND IMPLICATIONS: Non-invasive tests currently used to identify patients with advanced fibrosis or cirrhosis, such as fibrosis-4 index and liver stiffness measurement by vibration-controlled transient elastography, have high negative predictive values but high false positive rates, while results are indeterminate for a large number of cases. This study provides scores that will help the clinician diagnose advanced fibrosis or cirrhosis. These new easy-to-implement scores will help liver specialists to better identify (1) patients who need more intensive follow-up, (2) patients who should be referred for inclusion in therapeutic trials, and (3) which patients should be treated with pharmacological agents when effective therapies are approved.
MATERIALS AND METHODS: We retrospectively enrolled patients who underwent the procedure from January 2018 to April 2022. Under real time ultrasound (Hitachi Medical ProSound F37), thoracic lesions adjacent to the chest wall were sampled with a full-core biopsy needle (CT Core Single Action Biopsy Device, 18G × 15 cm, Vigeo, Italy). Chest x-ray was performed 30 minutes post procedure ruling out pneumothorax. Patients were discharged home 1-2 hours post biopsy. Data was analysed using Microsoft Excel 2010 and Statistical Package for Social Science (SPSS) Version 26.
RESULTS: A total of 18 patients (14 males, 4 females) underwent USLB for lung tumours. Biopsies were histologically deemed adequate with an overall diagnostic yield of 77.8% (14/18). A total of 57% were positive for thoracic malignancy (21% squamous cell carcinoma, 21% adenocarcinoma, 15% small cell carcinoma) and another 43% were positive for extra thoracic malignancy (1 hepatocellular carcinoma, 2 DLBCL, 1 Hodgkin's lymphoma, 1 seminoma, 1 thymoma). Four patients had inconclusive results but managed to get positive results from surgical or lymph node biopsy (thymoma and adenocarcinoma). Statistical analysis showed more than two passes are needed to achieve a positive HPE yield (p value<0.05). There were nil complications to all the cases done.
CONCLUSIONS: USLB can safely and effectively be performed by trained pulmonologists with excellent accuracy and low complication rate in outpatients.