RANDOMIZED CLINICAL TRIAL COMPARING ERCP VS ERCP PLUS EUS-GUIDED GALLBLADDER DRAINAGE (EUS-GBD) IN NON-SURGICAL PATIENTS WITH SYMPTOMATIC CHOLEDOCHOLITIASIS: MID-TERM ANALYSIS.

Aims
ERCP remains the primary approach to choledocolithiasis. 30% of patients who undergo clearance of choledocholitiasis by ERCP without subsequent cholecystectomy will suffer recurrent biliary events. We hypothesized that EUS-GBD performed in the same endoscopic procedure could significantly decrease this risk.

Methods
Multicenter randomized clinical trial. Subjects >75 years with Charlson comorbidity index(CCI)≥4 and symptomatic choledocholithiasis scheduled for ERCP were eligible. Concurrent acute cholecystitis, altered upper GI anatomy, lack of EUS window, potential surgical candidacy and failed ERCP were exclusion criteria. Participating subjects were randomized to ERCP vs ERCP combined with EUS-GBD. A 1-year follow-up was scheduled. The primary outcome was hospital readmission due to gallstone-related disease or procedure-related adverse events. Overall survival, all-cause admissions, adverse events and quality of life were also evaluated. Kaplan-Meier curves and log-rank tests were used to assess the primary and main secondary outcomes.

Results
74 patients have been included, 37 subjects in each group,(49.3% of estimated sample size). Baseline characteristics were balanced between cohorts (table 1). Sphincterotomy was performed in all ERCP patients and in 35 (94.6%) of ERCP-EUS-GBD patients. EUS-GBD was performed using 10x10mm (25 patients, 67.6%) and 15x10mm (12 patients, 32.4%) LAMS. The duodenum was the point of access in 21 (56.8%) subjects, the stomach in the remaining 16 (43.2%).

ERCP group presented a higher risk of readmission, p=0.05. The 1-year readmission risk was higher in the ERCP (27.5% [95% CI: 14.3-48.9%]) than in the ERCP+EUS-GBD group (5.7% [1.5-20.8%]). In the ERCP-EUS-GBD group 2 (5.4%) patients were readmitted due to moderately severe sphincterotomy-related bleedings. In the ERCP group 8 (21.6%) patients were readmitted; 3 presented acute cholecystitis, 3 developed acute cholangitis and 2 patients underwent scheduled cholecystectomy due to ongoing biliary pain,
No differences were observed in the 1-year mortality (12.6% [4.9-30.3%] in the ERCP group vs 23.1% [11-44.5%] in the ERCP+EUS-GBD, p=0.61) or the 1-year all-cause admission risk, ERCP: 33.5% (19.1-54.4%) ERCP+EUS-GBD: 36.3% (22.9-54.2%), p=0.40, although the ERCP+EUS-GBD presented a numerically higher number of admissions during the first 3 months. Adverse events rates were comparable, 13.5% in the ERCP group and 16.2% in the ERCP+EUS-GBD group. No differences in the quality of life were observed.

Conclusions
In non-surgical patients with symptomatic choledocholithiasis, performing EUS-GBD in the same endoscopic procedure as the ERCP reduces the risk of subsequent gallstone-related admissions, without an increased risk of adverse events or a longer hospital admission.