In this prospective multicenter study, we found that although competence cannot be confirmed for all AETs at the end of training, most meet QI thresholds for EUS and ERCP at the end of their first year of independent practice. This finding affirms the effectiveness of training programs. Clinicaltrials.gov ID NCT02509416.
Background and Aims-Minimum EUS and ERCP volumes that should be offered per trainee in "high quality" advanced endoscopy training programs (AETPs) are not established. We aimed to define the number of procedures required by an "average" advanced endoscopy trainee (AET) to achieve competence in technical and cognitive EUS and ERCP tasks to help structure AETPs. Methods-ASGE-recognized AETPs were invited to participate; AETs were graded on every fifth EUS and ERCP examination using a validated tool. Grading for each skill was done using a 4-point scoring system and learning curves (LCs) using cumulative sum (CUSUM) analysis for overall, technical, and cognitive components of EUS and ERCP were shared with AETs and trainers quarterly. Generalized linear mixed effects models with a random intercept for each AET were used to generate aggregate LCs allowing us to use data from all AETs to estimate the average learning experience for trainees. Results-Among 62 invited AETPs, 37 AETs from 32 AETPs participated. The majority of AETs reported hands-on EUS (52%, median 20 cases) and ERCP (68%, median 50 cases) experience before starting an AETP. The median number of EUS and ERCPs performed/AET was 400 (range 200-750) and 361 (250-650), respectively. Overall, 2616 examinations were graded
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).
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