Objective The optimal management of acute cholecystitis in patients at very high risk for cholecystectomy is uncertain. The aim of the current study was to compare endoscopic ultrasound (EUS)-guided gallbladder drainage (EUS-GBD) to percutaneous cholecystostomy (PT-GBD) as a definitive treatment in these patients under a randomised controlled trial. Design Consecutive patients suffering from acute calculous cholecystitis but were at very high-risk for cholecystectomy were recruited. The primary outcome was the 1-year adverse events rate. Secondary outcomes include technical and clinical success, 30-day adverse events, pain scores, unplanned readmissions, re-interventions and mortalities. Results Between August 2014 to February 2018, 80 patients were recruited. EUS-GBD significantly reduced 1 year adverse events (10 (25.6%) vs 31 (77.5%), p<0.001), 30-day adverse events (5 (12.8%) vs 19 (47.5%), p=0.010), re-interventions after 30 days (1/39 (2.6%) vs 12/40 (30%), p=0.001), number of unplanned readmissions (6/39 (15.4%) vs 20/40 (50%), p=0.002) and recurrent cholecystitis (1/39 (2.6%) vs 8/40 (20%), p=0.029). Postprocedural pain scores and analgesic requirements were also less (p=0.034). The technical success (97.4% vs 100%, p=0.494), clinical success (92.3% vs 92.5%, p=1) and 30-day mortality (7.7% vs 10%, p=1) were statistically similar. The predictor to recurrent acute cholecystitis was the performance of PT-GBD (OR (95% CI)=5.63 (1.20–53.90), p=0.027). Conclusion EUS-GBD improved outcomes as compared to PT-GBD in those patients that not candidates for cholecystectomy. EUS-GBD should be the procedure of choice provided that the expertise is available after a multi-disciplinary meeting. Further studies are required to determine the long-term efficacy. Trial registration number NCT02212717

Background Recent evidence suggests that endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is an effective and safe alternative to percutaneous drainage (PT-GBD). We conducted a systematic review and meta-analysis to compare these two procedures in high risk surgical patients with acute cholecystitis. Methods A comprehensive electronic literature search was conducted for all articles published up to October 2017 to identify comparative studies between EUS-GBD and PT-GBD. A meta-analysis was performed on outcomes including technical success, clinical success, post-procedure adverse events, length of hospital stay, unplanned hospital readmission, need for reintervention, recurrent cholecystitis, and disease- or treatment-related mortality for these two procedures. Results Five comparative studies (206 patients in the EUS-GBD group vs. 289 patients in the PT-GBD group), were included in the final analysis. There were no statistically significant differences in technical success (odds ratio [OR] 0.43, 95 % confidence interval [CI] 0.12 to 1.58; P = 0.21; I ² = 0 %) and clinical success (OR 1.07, 95 %CI 0.36 to 3.16; P = 0.90; I ² = 44 %) between the two procedures. EUS-GBD had fewer adverse events than PT-GBD (OR 0.43, 95 %CI 0.18 to 1.00; P = 0.05; I ² = 66 %). Moreover, patients undergoing EUS-GBD had shorter hospital stays, with pooled standard mean difference of – 2.53 (95 %CI – 4.28 to – 0.78; P = 0.005; I ² = 98 %), and required significantly fewer reinterventions (OR 0.16, 95 %CI 0.04 to 0.042; P < 0.001; I ² = 32 %) resulting in significantly fewer unplanned readmissions (OR 0.16, 95 %CI 0.05 to 0.53; P = 0.003; I ² = 79 %). Conclusions EUS-GBD was associated with lower rates of post-procedure adverse events, shorter hospital stays, and fewer reinterventions and readmissions compared with PT-GBD in patients with acute cholecystitis who were unfit for surgery.