ABSTRACT
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 69.5â% (95â% confidence interval [CI] 56.1â%â-â80.8â%) vs. 87.3â% (95â%CI 76.5â%â-â94.4â%), respectively (Pâ=â0.02). 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: 80.4â% (95â%CI 66.9â%â-â90.2â%) vs. 87.3â% (95â%CI 76.5â%â-â94.4â%; Pâ=â0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm: 100â% (95â%CI 94.3â%â-â100â%) vs. 86.4â% (95â%CI 75.0â%â-â94.0â%), respectively (Pâ=â0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95â%CI 0.47â-â0.97). 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.
