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, vol. 74, pp. 246–254
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.
Authors 27
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands
Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands a.m.onnekink@lumc.nl
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, and Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands
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University of Oxford · Oxford University Hospitals NHS Trust
Affiliation as printed
Department of Gastroenterology, Oxford University Hospitals NHS Foundation Trust, Oxford, UK
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Affiliation as printed
Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, The Netherlands
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Utrecht University · University Medical Center Utrecht
Affiliation as printed
Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, The Netherlands
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Complejo Hospitalario Universitario de Santiago
Affiliation as printed
Department of Gastroenterology and Hepatology, University Hospital of Santiago de Compostela, Santiago de Compostela, Spain
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Affiliation as printed
Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, The Netherlands
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands
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Elisabeth-TweeSteden Ziekenhuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, The Netherlands
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Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam UMC, location Vrije Universiteit, and, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands
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Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam UMC, location Vrije Universiteit, and, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands
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University Medical Center Groningen
Affiliation as printed
Department of Gastroenterology and Hepatology, University Medical Centre Groningen, Groningen, The Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Hospital, Amsterdam, The Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, 's-Hertogenbosch, The Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands
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Spaarne Ziekenhuis · Spaarne Gasthuis
Affiliation as printed
Department of Gastroenterology and Hepatology, Spaarne Gasthuis, Hoofddorp, The Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, and Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands
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The Netherlands Cancer Institute
Affiliation as printed
Department of Gastrointestinal Oncology, Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Haga Hospital, Den Haag, The Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam UMC, location University of Amsterdam, and Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands
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Affiliation as printed
Department of Gastroenterology and Hepatology, Sint Antonius Hospital, Nieuwegein, The Netherlands
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Amsterdam University Medical Centers · Amsterdam Gastroenterology Endocrinology Metabolism · Amsterdam UMC Location Vrije Universiteit Amsterdam
Affiliation as printed
Department of Gastroenterology and Hepatology, Amsterdam UMC, location Vrije Universiteit, and, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC, Amsterdam, The Netherlands
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Leiden University · Leiden University Medical Center
Affiliation as printed
Department of Gastroenterology and Hepatology, Leiden University Medical Centre, Leiden, The Netherlands
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