19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study.

BACKGROUND: The aim of this prospective multicenter study was to compare a flexible 19 G needle with nitinol shaft (19 G Flex) with a standard 22 G needle for transduodenal endoscopic ultrasound (EUS)-guided sampling of pancreatic head tumors. METHODS: Patients with pancreatic head tumors requiring tissue diagnosis were randomized into two arms: puncture with either a 19 G Flex needle or a 22 G needle. The primary end point was diagnostic accuracy for malignancy. The secondary end points were ergonomic scores, sample cytohistological quality, and complications. A 6-month follow-up was performed. RESULTS: 125 patients were randomized and 122 were analyzed: 59 patients in the 19 G Flex arm and 63 patients in the 22 G arm. The final diagnosis was malignancy in 111 patients and benign condition in 11. In intention-to-treat analysis, the diagnostic accuracy for malignancy of the 19 G Flex and 22 G needles was 69.5 % (95 % confidence interval [CI] 56.1 % - 80.8 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %), respectively (P = 0.02). In per-protocol analysis excluding eight technical failures in the 19 G Flex group, the diagnostic accuracy of the 19 G Flex and 22 G needles was not statistically different: 80.4 % (95 %CI 66.9 % - 90.2 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %; P = 0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm: 100 % (95 %CI 94.3 % - 100 %) vs. 86.4 % (95 %CI 75.0 % - 94.0 %), respectively (P = 0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95 %CI 0.47 - 0.97). CONCLUSION : The 19 G Flex needle was inferior to a standard 22 G needle in diagnosing pancreatic head cancer and more difficult to use in the transduodenal approach.

Real-life management of dual antiplatelet therapy interruption: the REGINA survey.

BACKGROUND: Concern about procedure-related bleeding is a major reason for premature discontinuation of dual oral antiplatelet therapy (APT); treatment cessation is detrimental in patients with coronary artery disease (CAD), especially after drug-eluting stent (DES) placement. The nationwide REGINA survey was designed to evaluate how the interruption of dual APT is managed in the 'real world'. METHODS: Physicians (2700/4581) were randomly selected to participate in a computer-assisted telephone interview. Knowledge about DES and APT was appraised by multiple-choice questions. Strategies for temporary interruption of dual APT before an invasive or surgical procedure were evaluated using 21 scenarios, including high-risk (30 days after DES) and low-risk (18 months after DES) periods. RESULTS: Out of 2700 practitioners, 2515 completed the interview. Rates of correct answers to basic knowledge questions ranged from 0% (dentists) to 52% (cardiologists). Unjustified total interruption of dual APT was much more frequent than expected (22.0% vs. 11.8%). A strategy of total interruption was less frequently chosen in the period of high ischemic risk compared to the low-risk period (13.7% vs. 31.1%, p<0.0001). Dual APT interruption in patients who require additional invasive cardiac or surgical procedures depended on type of physician consulted (more frequent in specialists than general practitioners or dentists), and on the physician's age and practice type (rural/private vs. urban/hospital). Correct answers were more frequently given in situations bearing a major risk, either ischemic or bleeding risk, than in those with no risk (49.2% vs. 30.2%, p<0.0001). Low-molecular-weight heparin was the substitution therapy in over two-thirds of scenarios and was associated with longer periods of APT interruption. INTERPRETATION: Adequate management of APT in patients with intracoronary stents who undergo potentially haemorrhagic invasive procedures depends mainly on the type of physician involved and their practice rather than on a carefully weighted assessment of ischemic/bleeding risk. Our findings suggest a lack of scientific evidence, insufficient knowledge of guidelines, and poor communication between physicians managing these patients.