Endoscopic Ultrasound Guided Liver Biopsy And Portal Pressure Gradient Measurement Compared To The Transjugular Approach: A Randomized Controlled Trial

Aims The transjugular (TJ) technique is the gold standard to simultaneously evaluate portal hypertension and liver fibrosis, with the hepatic venous pressure gradient (HVPG) and liver biopsy (LB), respectively. Recently, Endoscopic Ultrasound (EUS) has emerged as a novel approach capable of measuring portal pressure gradient (PPG) and performing LB. We hypothesize that EUS will yield higher-quality LB than TJ and also provide reliable PPG measurements. To date, no randomized controlled trial (RCT) has compared EUS to TJ.

Methods This single center RCT included adults evaluated for liver fibrosis and portal hypertension. Participants were randomly assigned to EUS or TJ for simultaneous HVPG/PPG and LB. The TJ technique was performed as per standard of care (low-dose midazolam, 18G TJ-LB system, and balloon wedge-pressure catheter). EUS was performed under conscious sedation with ketamine and low-dose midazolam. EUS-PPG was done using a 25G needle (EchoTip Insight, Cook Medical) and LB with a 19G needle (Acquire, Boston Scientific). The primary endpoint was the proportion of high-quality LB (AASLD criteria:≥25mm total aggregate length and≥11 complete portal tracts using 2 or 3 passes) with consistent HVPG/PPG (duplicate or triplicate measures within≤1mmHg). Secondary endpoints included technical success (obtaining a LB and HVPG/PPG), procedure time, LB- and HVPG/PPG-related outcomes, adverse events (AE, ASGE grading at day 7) and patient satisfaction (patient sedation satisfaction instrument, PSSI). We conducted an intent-to-treat analysis, reporting n (%) and mean (SD), with statistical significance defined as a two-tailed p-value≤0.05.

Results A total of 58 patients were randomized, 29 to EUS and 29 to TJ (56.6 [14.7] years old, 37.9% female, 50% MASLD, 67.2% cirrhosis). The primary endpoint was met in 24 (82.8%) patients for EUS vs 12 (41.4%) patients for TJ (p<0.01). Technical success occurred in 26 (90.0%) patients for EUS vs 28 (96.6%) patients for TJ (p=0.61). The procedure time was 20.7 (4.8) minutes for EUS and 48.8 (14.0) minutes for TJ (p<0.01). Mean total aggregate length was EUS: 117 (83.7) mm vs TJ: 29.2 (9.5) mm (p<0.01), complete portal tracts per specimen: EUS: 29.2 (18.7) vs TJ: 11.2 (5.8) (p<0.01), maximal length of single core: EUS: 25.3 (17.1) mm vs TJ: 13.6 (3.8) mm (p<0.01), number of passes: EUS: 2.1 (0.3) vs TJ: 2.3 (0.5) (p=0.02). Reliable HVPG/PPG was obtained in 26 (89.7%) patients for EUS vs 17 (58.6%) patients for TJ (p<0.01). All AEs were mild, including 2 (6.9%) for EUS and 3 (10.3%) in TJ. As per PSSI, total patient satisfaction with sedation was higher for EUS (p<0.01).

Conclusions While both procedures had similar technical success and safety profile, EUS is superior to TJ for the simultaneous acquisition of high-quality LB, consistent PPG, and patient satisfaction with sedation. In the well-selected cases, EUS is therefore preferable to TJ, paving the way for a significant shift in practice.