Department of Surgery, The Chinese University of Hong Kong, Hong Kong, China
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Wakayama, Japan.
Gut. 2020 Jun;69(6):1085-1091. doi: 10.1136/gutjnl-2019-319996. Epub 2020 Mar 12.
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.
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.
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).
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.
NCT02212717.
对于接受胆囊切除术风险极高的急性胆囊炎患者，最佳治疗方法尚不确定。本研究旨在通过随机对照试验比较超声内镜（EUS）引导下胆囊引流（EUS-GBD）与经皮胆囊造口术（PT-GBD）作为这些患者的确定性治疗方法。
连续招募患有急性胆石性胆囊炎但接受胆囊切除术风险极高的患者。主要结局是 1 年不良事件发生率。次要结局包括技术和临床成功率、30 天不良事件、疼痛评分、非计划性再入院、再干预和死亡率。
2014 年 8 月至 2018 年 2 月，共招募了 80 名患者。EUS-GBD 可显著降低 1 年不良事件发生率（10（25.6%）与 31（77.5%），p<0.001）、30 天不良事件发生率（5（12.8%）与 19（47.5%），p=0.010）、30 天后再干预率（1/39（2.6%）与 12/40（30%），p=0.001）、非计划性再入院率（6/39（15.4%）与 20/40（50%），p=0.002）和复发性胆囊炎发生率（1/39（2.6%）与 8/40（20%），p=0.029）。术后疼痛评分和镇痛需求也较低（p=0.034）。技术成功率（97.4%与 100%，p=0.494）、临床成功率（92.3%与 92.5%，p=1）和 30 天死亡率（7.7%与 10%，p=1）在统计学上无显著差异。复发性急性胆囊炎的预测因素是 PT-GBD 的实施（OR（95%CI）=5.63（1.20-53.90），p=0.027）。
与 PT-GBD 相比，EUS-GBD 可改善不适合接受胆囊切除术患者的预后。在多学科会议确定专家意见后，EUS-GBD 应作为首选治疗方法。需要进一步研究以确定其长期疗效。
NCT02212717。
