Article: Randomized controlled trial comparing the Franseen needle with a Fork-tip needle for EUS-guided fine-needle biopsy
Authors: Munish Ashat, Jagpal S Klair, Sydney L Rooney, Sagar J Vishal, Chris Jensen, Arvind R Murali, Nadav Sahar, Rami El-Abiad, Henning Gerke
Journal: Gastrointest Endosc. 2020 Jun 8;S0016-5107(20)34407-2
Background and aims: Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) primarily provides cytologic samples. EUS-guided fine-needle biopsy (EUS-FNB) with needles that provide histologic specimens may enhance diagnostic yield and facilitate accessory tissue staining. Several different needle designs are currently available and design superiority is unknown. We designed a randomized controlled trial (RCT) comparing 2 commonly used EUS-FNB needles in their ability to provide histologic tissue samples (primary endpoint) and to reach an accurate diagnosis (secondary endpoint).
Materials and methods: A total of 150 lesions from 134 patients (November 2018-June 2019) were randomized 1:1 between biopsies with a Franseen needle and a Fork-tip needle. Both groups were compared regarding the quality of the tissue samples and diagnostic accuracy.
Results: Of 150 lesions, 75 were pancreatic and 75 were other solid lesions in and around the GI tract. There was no statistically significant difference between the Franseen needle and the Fork-tip needle in the yield of adequate histological samples, 71 out of 75 (94.7%) versus 72 out of 75 (96%), (p=1.00), an absolute difference of -1.3% (95% CI, -8.1 to 5.4%). Similarly the 2 groups were similar in the diagnostic accuracy of histological analysis, 64 out of 75 (85.3%) versus 68 out of 75 (90.7%), (p=0.45), absolute difference -5.4% (95% CI, -15.7 to 5%); and in the diagnostic accuracy of combined cytological and histological analysis, 65 out of 75 (86.7%) versus 69/75 (92%), p=0.43, absolute difference -5.3%, (95% CI, -15.2% to 4.5%).
Conclusions: There was no significant difference in the performance of Franseen versus Fork-tip needles. Both needles achieved a high yield of histological tissue samples and high diagnostic accuracy.
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