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

中文翻译：

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超声内镜引导的胆囊引流术与经皮胆囊造口术在极高危手术急性胆囊炎患者中的比较：一项国际随机多中心对照优势试验 (DRAC 1)

目的 胆囊切除术风险极高的急性胆囊炎患者的最佳治疗方案尚不确定。本研究的目的是在随机对照试验中比较内镜超声 (EUS) 引导的胆囊引流 (EUS-GBD) 与经皮胆囊造口术 (PT-GBD) 作为这些患者的最终治疗方法。设计 连续招募患有急性结石性胆囊炎但胆囊切除术风险非常高的患者。主要结果是 1 年不良事件发生率。次要结果包括技术和临床成功、30 天不良事件、疼痛评分、意外再入院、再次干预和死亡率。结果 2014年8月至2018年2月，共招募患者80例。EUS-GBD 显着减少了 1 年不良事件 (10 (25.6%) vs 31 (77.5%)，p<0)。001)，30 天不良事件（5 (12.8%) 对 19 (47.5%)，p=0.010），30 天后再次干预（1/39（2.6%）对 12/40（30%），p） =0.001)，计划外再入院次数（6/39（15.4%）与 20/40（50%），p=0.002）和复发性胆囊炎（1/39（2.6%）与 8/40（20%），p） =0.029）。术后疼痛评分和镇痛要求也较低（p=0.034）。技术成功（97.4% 对 100%，p=0.494）、临床成功（92.3% 对 92.5%，p=1）和 30 天死亡率（7.7% 对 10%，p=1）在统计学上相似。复发性急性胆囊炎的预测因子是 PT-GBD 的表现（OR (95% CI)=5.63 (1.20–53.90)，p=0.027）。结论 在不适合胆囊切除术的患者中，EUS-GBD 与 PT-GBD 相比改善了结果。EUS-GBD 应该是选择的程序，前提是在多学科会议后可以获得专业知识。需要进一步的研究来确定长期疗效。试验注册号 NCT02212717