Gastrointestinal endoscopy · 2026
Endoscopic ultrasound-guided biopsy using a 19-gauge Franseen needle versus percutaneous ultrasound-guided biopsy using an 18-gauge full-core cutting needle for parenchymal liver disease: a randomized, controlled, noninferiority trial.
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Johri Ishank, Bhatia Vikram, Mukund Amar, Rastogi Archana, Bihari Chaggan, Singh Srajit, Vijayaraghavan Rajan, Chand Phool, Daniel Jaifrin
Аннотация
BACKGROUND AND AIMS: There are limited data comparing EUS-guided liver biopsy (EUS-LB) with percutaneous US-guided LB (PC-LB) regarding tissue adequacy, histologic yield, adverse events, and patient satisfaction.
METHODS: In this single-center, parallel-group, noninferiority trial, we randomized participants 1:1 to EUS-LB (19-gauge Franseen-tip biopsy needle; modified wet-heparin suction; left and right lobe) or PC-LB (18-gauge BioPince full-core needle [Argon Medical Devices]; right lobe). The primary end point was specimen adequacy, defined as total specimen length (TSL) ≥15 mm and complete portal tracts (CPTs) ≥8. Noninferiority was assessed using the absolute risk difference with a prespecified margin of -10%.
RESULTS: Ninety participants were randomized. In intention-to-treat analysis, the primary end point was achieved in 44 of 45 (97.8%) participants in the EUS-LB group and 29 of 45 (64.4%) participants in the PC-LB group (risk difference, 33.3%; 95% CI, 17.9%-48.1%), meeting noninferiority and demonstrating superiority (P < .001). With EUS-LB and PC-LB, the median TSL was 6.9 cm versus 2.0 cm, and the median CPT number was 42 versus 9, respectively (both P < .001). Even a single pass of EUS-LB outperformed PC-LB, with respect to sample adequacy, TSL, total CPT, and biopsy specimen area (all P < .001). PC-LB specimens were less fragmented (median 1 vs 13; P < .001) and had a greater median width (747.8 μm vs 667.2 μm; P < .001). Adverse events occurred more frequently with EUS-LB (26.7% vs 4.4%; P = .007); all but one were minor. Postprocedural pain was minimal, and satisfaction ratings were high in both groups.
CONCLUSIONS: EUS-LB was noninferior and superior to PC-LB for the prespecified adequacy end point, yielding a substantially greater specimen length and CPT counts, with more frequent but predominantly minor adverse events.
METHODS: In this single-center, parallel-group, noninferiority trial, we randomized participants 1:1 to EUS-LB (19-gauge Franseen-tip biopsy needle; modified wet-heparin suction; left and right lobe) or PC-LB (18-gauge BioPince full-core needle [Argon Medical Devices]; right lobe). The primary end point was specimen adequacy, defined as total specimen length (TSL) ≥15 mm and complete portal tracts (CPTs) ≥8. Noninferiority was assessed using the absolute risk difference with a prespecified margin of -10%.
RESULTS: Ninety participants were randomized. In intention-to-treat analysis, the primary end point was achieved in 44 of 45 (97.8%) participants in the EUS-LB group and 29 of 45 (64.4%) participants in the PC-LB group (risk difference, 33.3%; 95% CI, 17.9%-48.1%), meeting noninferiority and demonstrating superiority (P < .001). With EUS-LB and PC-LB, the median TSL was 6.9 cm versus 2.0 cm, and the median CPT number was 42 versus 9, respectively (both P < .001). Even a single pass of EUS-LB outperformed PC-LB, with respect to sample adequacy, TSL, total CPT, and biopsy specimen area (all P < .001). PC-LB specimens were less fragmented (median 1 vs 13; P < .001) and had a greater median width (747.8 μm vs 667.2 μm; P < .001). Adverse events occurred more frequently with EUS-LB (26.7% vs 4.4%; P = .007); all but one were minor. Postprocedural pain was minimal, and satisfaction ratings were high in both groups.
CONCLUSIONS: EUS-LB was noninferior and superior to PC-LB for the prespecified adequacy end point, yielding a substantially greater specimen length and CPT counts, with more frequent but predominantly minor adverse events.