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

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; Dutch Pancreatic Cancer Group

doi:10.1136/gutjnl-2024-332695

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

Gut. 2024 Oct 10:gutjnl-2024-332695. doi: 10.1136/gutjnl-2024-332695. Online ahead of print.

Authors

Anke M Onnekink¹, Myrte Gorris², Noor Lh Bekkali³, Philip Bos⁴, Paul Didden⁵, J Enrique Dominguez-Muñoz⁶, Pieter Friederich⁷, Emo E van Halsema⁸, Wouter L Hazen⁹, Nadine C van Huijgevoort¹⁰, Akin Inderson⁸, Maarten Ajm Jacobs¹⁰, Jan J Koornstra¹¹, Sjoerd Kuiken¹², Bob Ch Scheffer¹³, Hilbert Sloterdijk¹⁴, Ellert J van Soest¹⁵, Niels G Venneman¹⁶, Rogier P Voermans², Thomas R de Wijkerslooth¹⁷, Janneke Wonders¹⁸, Roeland Zoutendijk¹⁹, Serge Jlb Zweers²⁰, Paul Fockens², Robert C Verdonk¹⁹, Roy L J van Wanrooij¹⁰, Jeanin E Van Hooft⁸; Dutch Pancreatic Cancer Group

Affiliations

¹ Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands [email protected].
² Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, and Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands.
³ Department of Gastroenterology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
⁴ Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, The Netherlands.
⁵ Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands.
⁶ Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain.
⁷ Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands.
⁸ Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands.
⁹ Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands.
¹⁰ Department of Gastroenterology and Hepatology, Amsterdam UMC, location Vrije Universiteit, and, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands.
¹¹ Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands.
¹² Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands.
¹³ Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands.
¹⁴ Department of Gastroenterology and Hepatology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.
¹⁵ Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Hoofddorp, The Netherlands.
¹⁶ Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands.
¹⁷ Department of Gastrointestinal Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
¹⁸ Department of Gastroenterology and Hepatology, Haga Hospital, Den Haag, The Netherlands.
¹⁹ Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands.
²⁰ Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands.

PMID: 39389757
DOI: 10.1136/gutjnl-2024-332695

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.

Keywords: diagnostic and therapeutic endoscopy; endoscopic retrograde pancreatography; endoscopic sphincterotomy; hepatobiliary cancer; pancreatitis.