Nicolien J Schepers1, Nora D L Hallensleben2, Marc G Besselink3, Marie-Paule G F Anten4, Thomas L Bollen5, David W da Costa5, Foke van Delft6, Sven M van Dijk7, Hendrik M van Dullemen8, Marcel G W Dijkgraaf9, Casper H J van Eijck10, G Willemien Erkelens11, Nicole S Erler12, Paul Fockens6, Erwin J M van Geenen13, Janneke van Grinsven3, Robbert A Hollemans7, Jeanin E van Hooft6, Rene W M van der Hulst14, Jeroen M Jansen15, Frank J G M Kubben16, Sjoerd D Kuiken15, Robert J F Laheij17, Rutger Quispel18, Rogier J J de Ridder19, Marno C M Rijk20, Tessa E H Römkens21, Carola H M Ruigrok18, Erik J Schoon22, Matthijs P Schwartz23, Xavier J N M Smeets13, B W Marcel Spanier24, Adriaan C I T L Tan25, Willem J Thijs26, Robin Timmer27, Niels G Venneman28, Robert C Verdonk27, Frank P Vleggaar29, Wim van de Vrie30, Ben J Witteman31, Hjalmar C van Santvoort32, Olaf J Bakker7, Marco J Bruno33. 1. Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, Netherlands. Electronic address: n.schepers@antoniusziekenhuis.nl. 2. Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, Netherlands; Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, Netherlands. 3. Department of Surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Netherlands. 4. Department of Gastroenterology and Hepatology, Franciscus and Vlietland Hospital, Rotterdam, Netherlands. 5. Department of Radiology, St Antonius Hospital, Nieuwegein, Netherlands. 6. Department of Gastroenterology and Hepatology, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Netherlands. 7. Department of Surgery, St Antonius Hospital, Nieuwegein, Netherlands. 8. Department of Gastroenterology and Hepatology, University Medical Center Groningen, Groningen, Netherlands. 9. Department of Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, Netherlands. 10. Department of Surgery, Erasmus MC University Medical Center, Rotterdam, Netherlands. 11. Department of Gastroenterology and Hepatology, Gelre Hospital, Apeldoorn, Netherlands. 12. Department of Biostatistics, Erasmus MC University Medical Center, Rotterdam, Netherlands. 13. Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands. 14. Department of Gastroenterology and Hepatology, Spaarne Hospital, Haarlem, Netherlands. 15. Department of Gastroenterology and Hepatology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands. 16. Department of Gastroenterology and Hepatology, Maasstad Hospital, Rotterdam, Netherlands. 17. Department of Gastroenterology and Hepatology, Elisabeth-TweeSteden Hospital, Tilburg, Netherlands. 18. Department of Gastroenterology and Hepatology, Reinier de Graaf Group, Delft, Netherlands. 19. Department of Gastroenterology and Hepatology, Maastricht University Medical Center, Maastricht, Netherlands. 20. Department of Gastroenterology and Hepatology, Amphia Hospital, Breda, Netherlands. 21. Department of Gastroenterology and Hepatology, Jeroen Bosch Hospital, Den Bosch, Netherlands. 22. Department of Gastroenterology and Hepatology, Catharina Hospital, Eindhoven, Netherlands. 23. Department of Gastroenterology and Hepatology, Meander Medical Center, Amersfoort, Netherlands. 24. Department of Gastroenterology and Hepatology, Rijnstate Hospital, Arnhem, Netherlands. 25. Department of Gastroenterology and Hepatology, Canisius Wilhelmina Hospital, Nijmegen, Netherlands. 26. Department of Gastroenterology and Hepatology, Martini Hospital, Groningen, Netherlands. 27. Department of Gastroenterology and Hepatology, St Antonius Hospital, Nieuwegein, Netherlands. 28. Department of Gastroenterology and Hepatology, Medisch Spectrum Twente, Enschede, Netherlands. 29. Department of Gastroenterology and Hepatology, University Medical Center Utrecht, Utrecht, Netherlands. 30. Department of Gastroenterology and Hepatology, Albert Schweitzer Hospital, Dordrecht, Netherlands. 31. Department of Gastroenterology and Hepatology, Hospital Gelderse Vallei, Ede, Netherlands. 32. Department of Surgery, St Antonius Hospital, Nieuwegein, Netherlands; Department of Surgery, University Medical Center Utrecht, Utrecht, Netherlands. 33. Department of Gastroenterology and Hepatology, Erasmus MC University Medical Center, Rotterdam, Netherlands.
Abstract
BACKGROUND: It remains unclear whether urgent endoscopic retrograde cholangiopancreatography (ERCP) with biliary sphincterotomy improves the outcome of patients with gallstone pancreatitis without concomitant cholangitis. We did a randomised trial to compare urgent ERCP with sphincterotomy versus conservative treatment in patients with predicted severe acute gallstone pancreatitis. METHODS: In this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, patients with predicted severe (Acute Physiology and Chronic Health Evaluation II score ≥8, Imrie score ≥3, or C-reactive protein concentration >150 mg/L) gallstone pancreatitis without cholangitis were assessed for eligibility in 26 hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module with randomly varying block sizes to urgent ERCP with sphincterotomy (within 24 h after hospital presentation) or conservative treatment. The primary endpoint was a composite of mortality or major complications (new-onset persistent organ failure, cholangitis, bacteraemia, pneumonia, pancreatic necrosis, or pancreatic insufficiency) within 6 months of randomisation. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN97372133. FINDINGS: Between Feb 28, 2013, and March 1, 2017, 232 patients were randomly assigned to urgent ERCP with sphincterotomy (n=118) or conservative treatment (n=114). One patient from each group was excluded from the final analysis because of cholangitis (urgent ERCP group) and chronic pancreatitis (conservative treatment group) at admission. The primary endpoint occurred in 45 (38%) of 117 patients in the urgent ERCP group and in 50 (44%) of 113 patients in the conservative treatment group (risk ratio [RR] 0·87, 95% CI 0·64-1·18; p=0·37). No relevant differences in the individual components of the primary endpoint were recorded between groups, apart from the occurrence of cholangitis (two [2%] of 117 in the urgent ERCP group vs 11 [10%] of 113 in the conservative treatment group; RR 0·18, 95% CI 0·04-0·78; p=0·010). Adverse events were reported in 87 (74%) of 118 patients in the urgent ERCP group versus 91 (80%) of 114 patients in the conservative treatment group. INTERPRETATION: In patients with predicted severe gallstone pancreatitis but without cholangitis, urgent ERCP with sphincterotomy did not reduce the composite endpoint of major complications or mortality, compared with conservative treatment. Our findings support a conservative strategy in patients with predicted severe acute gallstone pancreatitis with an ERCP indicated only in patients with cholangitis or persistent cholestasis. FUNDING: The Netherlands Organization for Health Research and Development, Fonds NutsOhra, and the Dutch Patient Organization for Pancreatic Diseases.
BACKGROUND: It remains unclear whether urgent endoscopic retrograde cholangiopancreatography (ERCP) with biliary sphincterotomy improves the outcome of patients with gallstone pancreatitis without concomitant cholangitis. We did a randomised trial to compare urgent ERCP with sphincterotomy versus conservative treatment in patients with predicted severe acute gallstone pancreatitis. METHODS: In this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, patients with predicted severe (Acute Physiology and Chronic Health Evaluation II score ≥8, Imrie score ≥3, or C-reactive protein concentration >150 mg/L) gallstone pancreatitis without cholangitis were assessed for eligibility in 26 hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module with randomly varying block sizes to urgent ERCP with sphincterotomy (within 24 h after hospital presentation) or conservative treatment. The primary endpoint was a composite of mortality or major complications (new-onset persistent organ failure, cholangitis, bacteraemia, pneumonia, pancreatic necrosis, or pancreatic insufficiency) within 6 months of randomisation. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN97372133. FINDINGS: Between Feb 28, 2013, and March 1, 2017, 232 patients were randomly assigned to urgent ERCP with sphincterotomy (n=118) or conservative treatment (n=114). One patient from each group was excluded from the final analysis because of cholangitis (urgent ERCP group) and chronic pancreatitis (conservative treatment group) at admission. The primary endpoint occurred in 45 (38%) of 117 patients in the urgent ERCP group and in 50 (44%) of 113 patients in the conservative treatment group (risk ratio [RR] 0·87, 95% CI 0·64-1·18; p=0·37). No relevant differences in the individual components of the primary endpoint were recorded between groups, apart from the occurrence of cholangitis (two [2%] of 117 in the urgent ERCP group vs 11 [10%] of 113 in the conservative treatment group; RR 0·18, 95% CI 0·04-0·78; p=0·010). Adverse events were reported in 87 (74%) of 118 patients in the urgent ERCP group versus 91 (80%) of 114 patients in the conservative treatment group. INTERPRETATION: In patients with predicted severe gallstone pancreatitis but without cholangitis, urgent ERCP with sphincterotomy did not reduce the composite endpoint of major complications or mortality, compared with conservative treatment. Our findings support a conservative strategy in patients with predicted severe acute gallstone pancreatitis with an ERCP indicated only in patients with cholangitis or persistent cholestasis. FUNDING: The Netherlands Organization for Health Research and Development, Fonds NutsOhra, and the Dutch Patient Organization for Pancreatic Diseases.
Authors: Christina J Sperna Weiland; Celine B E Busch; Abha Bhalla; Marco J Bruno; Paul Fockens; Jeanin E van Hooft; Alexander C Poen; Hester C Timmerhuis; Devica S Umans; Niels G Venneman; Robert C Verdonk; Joost P H Drenth; Thomas R de Wijkerslooth; Erwin J M van Geenen Journal: J Hepatobiliary Pancreat Sci Date: 2021-12-21 Impact factor: 3.149
Authors: Mihai Faur; Sorin Radu Fleaca; Claudia Diana Gherman; Ciprian Ionut Bacila; Denisa Tanasescu; Dragos Serban; Laura Carina Tribus; Corneliu Tudor; Gabriel Catalin Smarandache; Daniel Ovidiu Costea; Mihail Silviu Tudosie; Dan Sabau; Gabriel Andrei Gangura; Ciprian Tanasescu Journal: Med Sci Monit Date: 2022-07-07
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