• Medicine · Mar 2021

    Randomized Controlled Trial Comparative Study

    Randomized controlled trial comparing a conventional needle and a novel needle for endoscopic ultrasound (EUS)-guided histology of peripancreatic masses.

    • Hyoun Wook Lee and Kwang Min Kim.
    • Department of Pathology.
    • Medicine (Baltimore). 2021 Mar 12; 100 (10): e25106e25106.

    IntroductionCytological study of samples obtained by Endoscopic ultrasound (EUS)-guided fine-needle aspiration (EUS-FNA) allows for recognition of clear signs of malignant transformation. However, certain neoplasms can be difficult to diagnose without histological analysis. Recently, a novel EUS-guided fine needle biopsy (EUS-FNB) needle was developed to increase tissue acquisition. This study set out to investigate the usefulness of this novel EUS-FNB needle (NEFN) in terms of obtaining a proper histology compared with a conventional EUS-FNA needle (CEFN).MethodsThis investigation was a prospective, single-blind, randomized study in a single academic hospital. Primary outcome was the acquisition rate of an appropriate and sufficient specimen for histologic assessment. Secondary outcomes were diagnostic yield of peripancreatic masses using a CEFN and a NEFN. Furthermore, we assessed the feasibility of determining K-ras mutation status according to needle type.ResultsThe study enrolled 56 consecutive patients. Technical success rates were 96.6% (28/29) for the CEFN and 100% (27/27) for the NEFN (P = 1.000). No complications occurred during or after the procedure in either needle group. An adequate sample for cytologic diagnosis was obtained in 89.7% (26/29) of patients in the CEFN group vs 96.3% (26/27) of patients in the NEFN group (P = .612). For histologic diagnosis, a sample with a biopsy adequacy score of 2 or more was obtained in 41.4% (12/29) of CEFN-acquired samples vs 88.9% (24/27) of NEFN-acquired samples (P < .001). K-ras mutation analysis using histologic specimens was possible in 13 (44.8%) CEFN-acquired samples and 25 (92.6%) of NEFN-acquired samples. This difference was significant (P < .001).ConclusionsThe present study suggests that the NEFN is an effective and reliable alternative compared to a CEFN in terms of tissue acquisition rate and quality of histologic sampling.Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

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