Teoh A Y, Perez-Miranda Manuel, Kunda Rastislav, Lee Sang Soo, Irani Shayan, Yeaton Paul, Sun Siyu, Baron Todd Huntley, Moon Jong Ho, Holt Bronte, Khor Christopher J L, Rerknimitr Rungsun, Bapaye Amol, Chan Shannon Melissa, Choi Hyun Jong, James Theodore William, Kongkam Pradermchai, Lee Yun Nah, Parekh Parth, Ridtitid Wiriyaporn, Serna-Higuera Carlos, Tan Damien M Y, Torres-Yuste Raul
Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, Hong Kong.
Department of Medicine, University Hospital Rio Hortega, Valladolid, Spain.
Endosc Int Open. 2019 Aug;7(8):E964-E973. doi: 10.1055/a-0915-2098. Epub 2019 Jul 24.
The aim of the current study was to review the outcomes of a large-scale international registry on endoscopic ultrasound-guided gallbladder drainage (EGBD) that encompasses different stent systems in patients who are at high-risk for cholecystectomy. This was a retrospective international multicenter registry on EGBD created by 13 institutions around the world. Consecutive patients who received EGBD for several indications were included. Outcomes include technical and clinical success, unplanned procedural events (UPE), adverse events (AEs), mortality, recurrent cholecystitis and learning curve of the procedure. Between June 2011 and November 2017, 379 patients were recruited to the study. Technical and clinical success were achieved in 95.3 % and 90.8 % of the patients, respectively. The 30-day AE rate was 15.3 % and 30-day mortality was 9.2 %. UPEs were significantly more common in patients with EGBD performed for conversion of cholecystostomy and symptomatic gallstones ( < 0.001); and by endoscopists with experience of fewer than 25 procedures ( = 0.033). Both presence of clinical failure ( = 0.014; RR 8.69 95 %CI [1.56 - 48.47]) and endoscopist experience with fewer than 25 procedures ( = 0.002; RR 4.68 95 %CI [1.79 - 12.26]) were significant predictors of 30-day AEs. Presence of 30-day AEs was a significant predictor of mortality ( < 0.001; RR 103 95 %CI [11.24 - 944.04]). EGBD was associated with high success rates in this large-scale study. EGBD performed for indications other than acute cholecystitis was associated with higher UPEs. The number of cases required to gain competency with the technique by experienced interventional endosonographers was 25 procedures.
本研究的目的是回顾一项关于内镜超声引导下胆囊引流术（EGBD）的大规模国际注册研究结果，该研究涵盖了不同支架系统，纳入了胆囊切除手术高风险患者。这是一项由全球13家机构创建的关于EGBD的回顾性国际多中心注册研究。纳入了因多种适应证接受EGBD的连续患者。结局指标包括技术成功和临床成功、非计划手术事件（UPE）、不良事件（AE）、死亡率、复发性胆囊炎以及该手术的学习曲线。在2011年6月至2017年11月期间，379例患者被纳入研究。技术成功率和临床成功率分别为95.3%和90.8%。30天不良事件发生率为15.3%，30天死亡率为9.2%。对于因胆囊造口术转换和有症状胆结石而进行EGBD的患者，非计划手术事件显著更常见（<0.001）；且在手术经验少于25例的内镜医师操作时更常见（=0.033）。临床失败（=0.014；RR 8.69 95%CI [1.56 - 48.47]）以及手术经验少于25例的内镜医师（=0.002；RR 4.68 95%CI [1.79 - 12.26]）均是30天不良事件的显著预测因素。30天不良事件的发生是死亡率的显著预测因素（<0.001；RR 103 95%CI [11.24 - 944.04]）。在这项大规模研究中，EGBD具有较高的成功率。针对急性胆囊炎以外适应证进行的EGBD与更高的非计划手术事件相关。经验丰富的介入性内镜超声医师熟练掌握该技术所需的病例数为25例手术。
