Prospective evaluation of an assessment tool for technical performance of duodenoscopes.

OBJECTIVE: While single-use and detachable-tip duodenoscopes have been recently developed to overcome risks of infection transmission, there are no reliable tools to objectively assess their technical performance. We evaluated the reliability and validity of a newly developed tool to assess the technical performance of reusable duodenoscopes. METHODS: An assessment tool was developed to measure duodenoscope performance based on three distinct criteria: maneuverability, mechanical/imaging characteristics and ability to perform requisite interventions. The assessment tool was tested prospectively on duodenoscopes used in endoscopic retrograde cholangiopancreatography (ERCP) procedures at nine academic medical centers over a 6-month period. The main outcome was reliability of the duodenoscope assessment tool, which was estimated using Cronbach's coefficient alpha (α). The secondary outcome was validity of the assessment tool. RESULTS: The assessment tool evaluated technical performance of reusable duodenoscopes in 1080 ERCP procedures. Indications were biliary in 92.8% and pancreatic in 7.2% procedures. The overall Cronbach's coefficient α for maneuverability was 0.81, assessment of mechanical/imaging characteristics was 0.92, and ability to perform requisite interventions was 0.87. On multiple linear regression analysis, prolonged procedure duration, older patient age and pancreatic interventions were significantly positively associated with higher (worse) scores. CONCLUSIONS: The newly developed assessment tool appears reliable and valid for evaluating the technical performance of duodenoscopes. Registration: ClinicalTrials.gov Identifier: NCT04004533.

In memoriam: Fine-needle aspiration, birth: Fine-needle biopsy: The changing trend in endoscopic ultrasound-guided tissue acquisition.

BACKGROUND AND AIM: Fine-needle aspiration (FNA) cytology has been the preferred technique for procuring tissue at endoscopic ultrasound (EUS) procedures for the past 25 years. To overcome some of the limitations of FNA cytology, fine-needle biopsy (FNB) has been recently developed to yield histological tissue. Main objective was to compare the diagnostic yield of FNB compared to FNA for both onsite and offsite specimen assessment. METHODS: A retrospective study was conducted at a single tertiary referral center to evaluate the outcomes of FNA and FNB over a 4-year period. EUS-guided tissue sampling was carried out using 22- or 25-G FNA needles from 2014 to 2015, and 22-G FNB needle was used from 2016 to 2017. RESULTS: Of 3020 patients undergoing EUS-guided sampling of solid mass lesions (pancreatic masses 71.3%, other lesions 28.7%), FNA was carried out in 68.9% and FNB in 31.1%. Median number of passes required for diagnostic adequacy on rapid onsite evaluation was significantly lower for FNB compared to FNA (1 [IQR: 1-2] vs 2 [IQR 1-3], P < 0.001). Diagnostic yield on cell block was also significantly superior with FNB compared to FNA (92.3 vs 71.1%, P < 0.001). The superior performance of FNB over FNA was observed for both pancreatic (P < 0.001) and non-pancreatic lesions (P < 0.001). CONCLUSION: Given these promising findings, in the future, EUS-guided FNB will likely be the preferred technique for sampling of solid mass lesions.