EUS-guided biopsy using 19-gauge Franseen needle versus percutaneous ultrasound-guided biopsy using 18-gauge full-core cutting needle for parenchymal liver disease: A randomized controlled, non-inferiority trial.

Authors

Ishank Johri, Vikram Bhatia, Amar Mukund, Archana Rastogi, Chaggan Bihari, Srajit Singh, Rajan Vijayaraghavan, Phool Chand, Jaifrin Daniel

Published in

Gastrointestinal endoscopy. Aug 11, 2026. Epub Aug 11, 2026.

Abstract

There is limited data comparing endoscopic ultrasound-guided liver biopsy (EUS-LB) with percutaneous ultrasound-guided liver biopsy (PC-LB) regarding tissue adequacy, histologic yield, adverse events, and patient satisfaction.
In this single-center, parallel-group, non-inferiority trial, we randomized participants 1:1 to EUS-LB (19-G Franseen-tip biopsy needle; modified wet-heparin suction; left and/or right lobe) or PC-LB (18-G BioPince™ full-core needle; right lobe). The primary endpoint was specimen adequacy, defined as total specimen length (TSL) ≥15 mm and complete portal tracts (CPT) ≥8. Non-inferiority was assessed using absolute risk difference with a prespecified margin of -10%.
Ninety participants were randomized. In intention-to-treat analysis, the primary endpoint was achieved in 44/45(97.8%) of EUS-LB and 29/45(64.4%) of PC-LB group (risk difference +33.3%; 95%CI: +17.9% to +48.1%), meeting non-inferiority and demonstrating superiority (p<0.001). With EUS-LB and PC-LB, the median TSL was 6.9cm versus 2.0cm and the median CPT number was 42 versus 9, respectively (both p<0.001). Even a single pass of EUS-LB outperformed PC-LB, with respect to sample adequacy, TSL, total CPT, and biopsy area (all p<0.001). PC-LB specimens were less fragmented (median 1 vs 13; p<0.001) and had greater median width (747.8μm vs. 667.2μm; p<0.001). Adverse events occurred more frequently with EUS-LB (26.7% vs. 4.4%; p=0.007); all but one were minor. Post-procedural pain was minimal, and satisfaction ratings were high in both groups.
EUS-LB was non-inferior and superior to PC-LB for the prespecified adequacy endpoint, yielding substantially greater specimen length and CPT counts, with more frequent but predominantly minor adverse events.
CTRI/2023/10/058529; NCT06047327.

PMID:
42580638
Bibliographic data and abstract were imported from PubMed on 12 Aug 2026.

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