内镜下括约肌切开术预防远端恶性胆道梗阻（SPHINX）置入自膨胀金属支架后发生 ERCP 后胰腺炎：一项多中心、随机对照试验。
Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial.
发表日期：2024 Oct 10
作者：
Anke M Onnekink, Myrte Gorris, Noor Lh Bekkali, Philip Bos, Paul Didden, J Enrique Dominguez-Muñoz, Pieter Friederich, Emo E van Halsema, Wouter L Hazen, Nadine C van Huijgevoort, Akin Inderson, Maarten Ajm Jacobs, Jan J Koornstra, Sjoerd Kuiken, Bob Ch Scheffer, Hilbert Sloterdijk, Ellert J van Soest, Niels G Venneman, Rogier P Voermans, Thomas R de Wijkerslooth, Janneke Wonders, Roeland Zoutendijk, Serge Jlb Zweers, Paul Fockens, Robert C Verdonk, Roy L J van Wanrooij, Jeanin E Van Hooft,
来源：
GUT
摘要：
内镜逆行胰胆管造影（ERCP）联合全覆膜自膨式金属支架（FCSEMS）置入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。 FCSEMS 放置前进行内镜下括约肌切开术可能会降低 PEP 风险。旨在比较 FCSEMS 放置前内镜下括约肌切开术与不进行括约肌切开术。这项多中心、随机、优越性试验在 17 家医院进行，纳入了疑似远端 MBO 的患者。在 ERCP 期间，患者在 FCSEMS 放置之前被随机分配接受内镜下括约肌切开术（括约肌切开术组）或不接受括约肌切开术（对照组）。主要结果是 30 天内的 PEP。次要结局包括手术相关并发症和 30 天死亡率。 50%的患者（n=259）完成随访后进行中期分析。2016年5月至2023年6月，意向治疗分析纳入297例患者，其中括约肌切开组156例，乳头括约肌切开术组141例。对照组。中期分析后，该研究因无效而提前终止。 PEP 在各组之间没有差异，括约肌切开术组有 26 名患者（17%）发生 PEP，而对照组有 30 名患者（21%）发生 PEP（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 天死亡率没有显着差异。该试验发现，在减少远端 MBO 患者的 PEP 方面，内镜下括约肌切开术并不优于不进行括约肌切开术。因此，没有足够的证据建议在 FCEMS 放置之前进行常规内镜括约肌切开术。NL5130.© 作者（或其雇主）2024。禁止商业重复使用。请参阅权利和权限。英国医学杂志出版。
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.To compare endoscopic sphincterotomy to no sphincterotomy prior to FCSEMS placement.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.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.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.NL5130.© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.