Ishank Johri, Vikram Bhatia, Amar Mukund, Archana Rastogi, Chaggan Bihari, Srajit Singh, Rajan Vijayaraghavan, Phool Chand, Jaifrin Daniel
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.
BACKGROUND AND AIMS: 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.
METHODS: 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%.
RESULTS: 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.
CONCLUSIONS: 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.
TRIAL REGISTRATION: CTRI/2023/10/058529; NCT06047327.