Abstract

Cutting needles are thought to be effective as biopsy needles. A few types of cutting needles are available for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and the Menghini-type needle is an end-type cutting needle. A prospective randomized controlled trial was conducted to compare the results of EUS-FNA using a Menghini-type needle (needle M) versus a conventional needle (needle S). The main eligibility criteria were as follows: patients with a pancreatic mass referred for EUS-FNA, ≥ 20years old, and a performance status < 4. The primary outcome was the sample quality. The secondary outcomes were factors associated with the sample quality, diagnostic accuracy, and adverse events. A total of 97 patients were enrolled in this study. The sample quality for total puncture with needle M (92.8%) was significantly higher than that with needle S (81.4%) (p = 0.0305). The tumor size (p = 0.033) and type of needle (p = 0.031) were significant factors associated with adequate tissue collection in univariate and multivariate analyses (odds ratio [OR] 2.71; 95% confidence interval [CI] 1.12-6.54; p = 0.027 for tumor size, and OR 2.93; 95% CI 1.23-8.21; p = 0.0153 for type of needle). The diagnostic accuracy of each needle was 88.7% (86/97) with needle M and 73.2% (71/97) with needle S. Adverse events occurred in 2 of the 97 patients (0.02%). A Menghini-type needle was able to obtain core tissue for histology more effectively than a conventional aspiration needle. UMIN registration number of 000020668.

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