Background and Study Aims: EUS-guided fine needle aspiration (EUS-FNA) is the standard in the diagnosis of pancreatic solid lesions, in particular when combined with rapid on-site evaluation of cytopathology (ROSE). More recently, a fork-tip needle for core biopsy (FNB) has been shown to be associated with excellent diagnostic yield. EUS-FNB alone; however, has not been compared to EUS-FNA+ROSE in a large clinical trial. Our aim is to compare EUS-FNB alone to EUS-FNA+ROSE in solid pancreatic lesions.
Patients and Methods: Multicenter non-inferiority RCT involving 7 centers. Solid pancreatic lesions referred for EUS were considered for inclusion. The primary endpoint is diagnostic accuracy. Secondary endpoints include sensitivity/specificity, mean number of needle passes, and cost.
Results: 235 patients were randomized: 115 EUS-FNB alone and 120 EUS-FNA+ROSE. Overall, 217 patients had a malignant histology. The diagnostic accuracy for malignancy of EUS-FNB alone was non-inferior to EUS-FNA+ROSE 92.2% (95% CI: 86.6-96.9%) and 93.3% (95% CI: 88.8-97.9%), respectively p=0.72. Diagnostic sensitivity for malignancy was 92.5% (95% CI: 85.7-96.7%) EUS-FNB alone vs. 96.5% (93.0-98.6%) EUS-FNA+ROSE (p=0.46) while specificity was 100% in both. Adequate histology yield was obtained in 87.5% of the EUS-FNB alone samples. Mean number of needle of passes and procedure time favored EUS-FNB alone (2.3±0.6 passes vs. 3.0±1.1 passes p≤0.01 and 19.3±8.0 minutes vs. 22.7±10.8 minutes p <0.01). EUS-FNB alone cost on average 45USD more than EUS-FNA+ROSE.
Conclusion: EUS-FNB alone is non-inferior to EUS-FNA+ROSE and is associated with fewer needle passes, shorter procedure time, and excellent histological yield at comparable cost. (clinicaltrials.gov: NCT03435588).
OBJECTIVES:
The Finnegan Neonatal Abstinence Score (FNAS) monitors infants with neonatal abstinence syndrome (NAS), but it has been criticized for being time consuming and subjective. Many institutions have transitioned to a more straightforward screening tool, Eat, Sleep, Console (ESC), an assessment based on 3 simple observations with a focus on maximizing nonpharmacologic therapies. We aimed to compare the sensitivity and specificity of the ESC with that of the FNAS to determine if infants who needed pharmacologic therapy could potentially be missed when assessed by using ESC.
METHODS:
A retrospective cohort study of infants identified by International Classification of Diseases, Ninth Revision and International Classification of Diseases, 10th Revision billing codes for NAS. FNAS scores were recorded every 4 hours for the entire hospitalization. ESC proxy scores were created by using components of the FNAS that referenced eating, sleeping, and consoling. Detailed demographic and clinical data were manually extracted regarding opioid exposures and pharmacologic treatment of NAS.
RESULTS:
From 2013 to 2016, 423 infants ≥37 weeks’ gestation had a total of 33 115 FNAS scores over 921 days of observation. In total, 287 (68%) were exposed to buprenorphine, 100 (23.7%) were exposed to methadone, and 165 (39%) were pharmacologically treated. The FNAS was 94.8% sensitive and 63.5% specific for pharmacologic treatment, and the ESC proxy variables were 99.4% sensitive and 40.2% specific (P < .01).
CONCLUSIONS:
ESC proxy variables have slightly higher sensitivity compared with FNAS, suggesting that ESC use is unlikely to miss infants requiring treatment who would have been identified by FNAS. Transitioning from FNAS to ESC is not likely to impair the care of infants with NAS.
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