Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial.

IF 23 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY

Gut Pub Date : 2024-10-10 DOI:10.1136/gutjnl-2024-332695

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

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引用次数: 0

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.

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内镜下括约肌切开术预防自膨胀金属支架置入治疗远端恶性胆道梗阻后的 ERCP 后胰腺炎（SPHINX）：一项多中心随机对照试验。

背景：内镜逆行胰胆管造影术（ERCP）配合全覆盖自膨胀金属支架（FCSEMS）置入术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 置入术与ERCP 术后胰腺炎（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：比较在置入 FCSEMS 之前进行内镜下括约肌切开术和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，包括疑似远端 MBO 患者。患者在 ERCP 期间随机接受内镜下括约肌切开术（括约肌切开术组）或在放置 FCSEMS 之前不进行括约肌切开术（对照组）。主要结果是 30 天内的 PEP。次要结果包括手术相关并发症和 30 天死亡率。在50%的患者（n=259）完成随访后进行了中期分析：2016年5月至2023年6月期间，297名患者被纳入意向治疗分析，其中括约肌切开术组156人，对照组141人。中期分析后，该研究因无效而提前终止。括约肌切开术组有 26 名患者（17%）发生 PEP，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），组间无差异。在出血、穿孔、胆管炎、胆囊炎或30天死亡率方面没有明显差异：这项试验发现，在减少远端 MBO 患者的 PEP 方面，内镜下括约肌切开术并不比不做括约肌切开术更有优势。因此，没有足够的证据建议在放置 FCEMS 之前常规进行内镜下括约肌切开术：试验注册号：NL5130。

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来源期刊

Gut 医学-胃肠肝病学

CiteScore

45.70

自引率

2.40%

发文量

284

审稿时长

1.5 months

期刊介绍： Gut is a renowned international journal specializing in gastroenterology and hepatology, known for its high-quality clinical research covering the alimentary tract, liver, biliary tree, and pancreas. It offers authoritative and current coverage across all aspects of gastroenterology and hepatology, featuring articles on emerging disease mechanisms and innovative diagnostic and therapeutic approaches authored by leading experts. As the flagship journal of BMJ's gastroenterology portfolio, Gut is accompanied by two companion journals: Frontline Gastroenterology, focusing on education and practice-oriented papers, and BMJ Open Gastroenterology for open access original research.