Background Endoscopic retrograde cholangiopancreatography (ERCP) with fully covered self-expandable metal stent (FCSEMS) placement is the preferred approach for biliary drainage in patients with suspected distal malignant biliary obstruction (MBO). However, FCSEMS placement is associated with a high risk of post-ERCP pancreatitis (PEP). Endoscopic sphincterotomy prior to FCSEMS placement may reduce PEP risk. Objective To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement. Design This multicentre, randomised, superiority trial was conducted in 17 hospitals and included patients with suspected distal MBO. Patients were randomised during ERCP to receive either endoscopic sphincterotomy (sphincterotomy group) or no sphincterotomy (control group) prior to FCSEMS placement. The primary outcome was PEP within 30 days. Secondary outcomes included procedure-related complications and 30-day mortality. An interim analysis was performed after 50% of patients (n=259) had completed follow-up. Results Between May 2016 and June 2023, 297 patients were included in the intention-to-treat analysis, with 156 in the sphincterotomy group and 141 in the control group. After the interim analysis, the study was terminated prematurely due to futility. PEP did not differ between groups, occurring in 26 patients (17%) in the sphincterotomy group compared with 30 patients (21%) in the control group (relative risk 0.78, 95% CI 0.49 to 1.26, p=0.37). There were no significant differences in bleeding, perforation, cholangitis, cholecystitis or 30-day mortality. Conclusion This trial found that endoscopic sphincterotomy was not superior to no sphincterotomy in reducing PEP in patients with distal MBO. Therefore, there was insufficient evidence to recommend routine endoscopic sphincterotomy prior to FCEMS placement. Trial registration number NL5130. Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request. Individual patient data will be shared after deidentification and approval by the study team and Dutch Pancreatic Cancer Group.

中文翻译：

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内窥镜下括约肌切开术预防远端恶性胆道梗阻 （SPHINX） 自膨式金属支架置入后 ERCP 后胰腺炎：一项多中心、随机对照试验


背景 内窥镜逆行胰胆管造影术 （ERCP） 与全覆盖的自膨式金属支架 （FCSEMS） 放置是疑似远端恶性胆道梗阻 （MBO） 患者胆道引流的首选方法。然而，FCSEMS 放置与 ERCP 后胰腺炎 （PEP） 的高风险相关。在放置 FCSEMS 之前进行内镜下括约肌切开术可降低 PEP 风险。目的 比较内窥镜下括约肌切开术与放置 FCSEMS 前无括约肌切开术。设计 这项多中心、随机、优效性试验在 17 家医院进行，包括疑似远端 MBO 的患者。在 ERCP 期间，患者被随机分配接受内窥镜下括约肌切开术（括约肌切开术组）或无括约肌切开术（对照组），然后再放置 FCSEMS。主要结局是 30 天内的 PEP。次要结局包括手术相关并发症和 30 天死亡率。在 50% 的患者 （n=259） 完成随访后进行中期分析。结果 2016 年 5 月至 2023年6月期间，意向治疗分析纳入 297 例患者，其中括约肌切开组 156 例，对照组 141 例。在中期分析后，该研究因无效而提前终止。PEP 在组间没有差异，括约肌切开术组有 26 例患者 （17%） 发生，而对照组有 30 例患者 （21%） 发生 （相对风险 0.78,95% CI 0.49 至 1.26，p = 0.37）。出血、穿孔、胆管炎、胆囊炎或 30 天死亡率无显著差异。结论 该试验发现，内窥镜下括约肌切开术在降低远端 MBO 患者的 PEP 方面并不优于无括约肌切开术。 因此，没有足够的证据推荐在放置 FCEMS 之前进行常规内镜下括约肌切开术。试验注册号 NL5130。数据可根据合理要求提供。支持本研究结果的数据可应合理要求从通讯作者处获得。个体患者数据将在研究小组和荷兰胰腺癌组进行去标识化和批准后共享。