内镜括约肌切开术预防自膨式金属支架置入治疗远端恶性胆管梗阻后内镜逆行胰胆管造影术后胰腺炎（SPHINX）：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.

作者信息

Onnekink Anke M, Gorris Myrte, Bekkali Noor Lh, Bos Philip, Didden Paul, Dominguez-Muñoz J Enrique, Friederich Pieter, van Halsema Emo E, Hazen Wouter L, van Huijgevoort Nadine C, Inderson Akin, Jacobs Maarten Ajm, Koornstra Jan J, Kuiken Sjoerd, Scheffer Bob Ch, Sloterdijk Hilbert, van Soest Ellert J, Venneman Niels G, Voermans Rogier P, de Wijkerslooth Thomas R, Wonders Janneke, Zoutendijk Roeland, Zweers Serge Jlb, Fockens Paul, Verdonk Robert C, van Wanrooij Roy L J, Van Hooft Jeanin E

机构信息

Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands

Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, and Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands.

出版信息

Gut. 2025 Jan 17;74(2):246-254. doi: 10.1136/gutjnl-2024-332695.

DOI:10.1136/gutjnl-2024-332695

PMID:39389757

Abstract

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.

摘要

背景

对于疑似远端恶性胆管梗阻（MBO）的患者，内镜逆行胰胆管造影术（ERCP）联合完全覆盖自膨式金属支架（FCSEMS）置入是胆道引流的首选方法。然而，FCSEMS置入与ERCP术后胰腺炎（PEP）的高风险相关。在FCSEMS置入前进行内镜括约肌切开术可能会降低PEP风险。

目的

比较FCSEMS置入前内镜括约肌切开术与不进行括约肌切开术的效果。

设计

这项多中心、随机、优效性试验在17家医院进行，纳入了疑似远端MBO的患者。患者在ERCP期间被随机分组，在FCSEMS置入前接受内镜括约肌切开术（括约肌切开术组）或不进行括约肌切开术（对照组）。主要结局是30天内发生的PEP。次要结局包括与手术相关的并发症和30天死亡率。在50%的患者（n = 259）完成随访后进行了中期分析。

结果

2016年5月至2023年6月期间，297例患者纳入意向性分析，其中括约肌切开术组156例，对照组141例。中期分析后，由于无效性，研究提前终止。两组之间的PEP无差异，括约肌切开术组26例患者（17%）发生PEP，而对照组30例患者（21%）发生PEP（相对风险0.78，95%CI 0.49至1.26，p = 0.37）。在出血、穿孔、胆管炎、胆囊炎或30天死亡率方面无显著差异。