Randomized Controlled Trial of Endoscopic Ultrasound-Guided Liver Biopsy Versus Percutaneous Liver Biopsy for Obtaining Histologically Adequate Specimens.

AIM: To compare endoscopic ultrasound-guided liver biopsy (EUS-LB) with percutaneous liver biopsy (P-LB) in terms of histological adequacy, safety, and patient-reported pain in parenchymal liver disease.

METHODS

In this single-center randomized controlled trial, 80 patients were assigned to either EUS-LB (n = 41) or P-LB (n = 39). The primary endpoint was histological adequacy, defined as total specimen length (TSL) ≥ 15 mm and ≥ 6 complete portal tracts (CPTs). The main secondary endpoints were the definitive histological diagnostic rate, specimen characteristics (CPTs, TSL, and longest specimen length), patient-reported pain, and procedure-related adverse events (AEs). EUS-LB employed a 19-gauge Franseen-tip needle with wet suction under conscious sedation, whereas P-LB used a 16-gauge Tru-Cut needle under local anesthesia.

RESULTS

Histological adequacy based on predefined histologic criteria was achieved more frequently with EUS-LB than with P-LB (70.7% vs. 10.3%; difference, 60.4%; 95% CI 43.5-77.3). The definitive histological diagnostic rates were similar (92.7% vs. 97.4%). The median TSL was longer with EUS-LB (20.0 vs. 12.8 mm), whereas ≥ 6 CPTs were more common with P-LB (97.4% vs. 80.5%). AEs occurred in 2.4% versus 25.6%, driven in the P-LB arm by procedural stress-related hemodynamic responses (transient grade III hypertension); patient-reported pain favored EUS-LB (no pain during the procedure, 95.1% vs. 30.8%). No serious AEs or bleeding events occurred, and none required prolonged hospitalization.

CONCLUSIONS

EUS-LB met the noninferiority criterion for histologic adequacy and achieved a diagnostic performance comparable to that of P-LB with lower patient-reported pain. EUS-LB may be a reasonable alternative when endoscopic expertise and sedation are available.