EUS-guided fine needle biopsy alone vs. EUS-guided fine needle aspiration with rapid on-site evaluation of cytopathology in pancreatic lesions: a multicenter randomized trial

Published on Jan 27, 2021in Endoscopy7.341
· DOI :10.1055/A-1375-9775
Yen-I. Chen1
Estimated H-index: 1
(MUHC: McGill University Health Centre),
Yen-I Chen7
Estimated H-index: 7
(MUHC: McGill University Health Centre)
+ 25 AuthorsClarence Wong13
Estimated H-index: 13
(Alexandra Hospital)
Sources
Abstract
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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