Sandra van Brunschot1, Janneke van Grinsven2, Hjalmar C van Santvoort3, Olaf J Bakker4, Marc G Besselink5, Marja A Boermeester5, Thomas L Bollen6, Koop Bosscha7, Stefan A Bouwense8, Marco J Bruno9, Vincent C Cappendijk10, Esther C Consten11, Cornelis H Dejong12, Casper H van Eijck13, Willemien G Erkelens14, Harry van Goor8, Wilhelmina M U van Grevenstein4, Jan-Willem Haveman15, Sijbrand H Hofker15, Jeroen M Jansen16, Johan S Laméris17, Krijn P van Lienden17, Maarten A Meijssen18, Chris J Mulder19, Vincent B Nieuwenhuijs20, Jan-Werner Poley9, Rutger Quispel21, Rogier J de Ridder22, Tessa E Römkens23, Joris J Scheepers24, Nicolien J Schepers9, Matthijs P Schwartz25, Tom Seerden26, B W Marcel Spanier27, Jan Willem A Straathof28, Marin Strijker5, Robin Timmer29, Niels G Venneman30, Frank P Vleggaar31, Rogier P Voermans32, Ben J Witteman33, Hein G Gooszen34, Marcel G Dijkgraaf35, Paul Fockens32. 1. Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands. Electronic address: s.vanbrunschot@pancreatitis.nl. 2. Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands; Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands. 3. Department of Surgery, St Antonius Hospital, Nieuwegein, Netherlands; Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands. 4. Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands. 5. Department of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands. 6. Department of Radiology, St Antonius Hospital, Nieuwegein, Netherlands. 7. Department of Surgery, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands. 8. Department of Surgery, Radboud University Medical Centre, Nijmegen, Netherlands. 9. Department of Gastroenterology and Hepatology, Erasmus MC, University Medical Centre, Rotterdam, Netherlands. 10. Department of Radiology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands. 11. Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands. 12. Department of Surgery and NUTRIM School for Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre, Maastricht, Netherlands. 13. Department of Surgery, Erasmus MC, University Medical Centre, Rotterdam, Netherlands. 14. Department of Gastroenterology, Gelre Hospital, Apeldoorn, Netherlands. 15. Department of Surgery, University Medical Centre Groningen, University of Groningen, Groningen, Netherlands. 16. Department of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands. 17. Department of Radiology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands. 18. Department of Gastroenterology, Isala Clinics, Zwolle, Netherlands. 19. Department of Gastroenterology, VU Medical Centre, Amsterdam, Netherlands. 20. Department of Surgery, Isala Clinics, Zwolle, Netherlands. 21. Department of Gastroenterology, Reinier de Graaf Group, Delft, Netherlands. 22. Department of Gastroenterology, Maastricht University Medical Centre, Maastricht, Netherlands. 23. Department of Gastroenterology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands. 24. Department of Surgery, Reinier de Graaf Group, Delft, Netherlands. 25. Department of Gastroenterology, Meander Medical Centre, Amersfoort, Netherlands. 26. Department of Gastroenterology, Amphia Hospital, Breda, Netherlands. 27. Department of Gastroenterology, Rijnstate Hospital, Arnhem, Netherlands. 28. Department of Gastroenterology, Máxima Medical Centre, Veldhoven, Netherlands. 29. Department of Gastroenterology, St Antonius Hospital, Nieuwegein, Netherlands. 30. Department of Gastroenterology, Medisch Spectrum Twente, Enschede, Netherlands. 31. Department of Gastroenterology and Hepatology, University Medical Centre Utrecht, Utrecht, Netherlands. 32. Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands. 33. Department of Gastroenterology, Hospital Gelderse Vallei, Ede, Netherlands. 34. Department of OR/Evidence Based Surgery, Radboud University Medical Centre, Nijmegen, Netherlands. 35. Clinical Research Unit, Academic Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
Abstract
BACKGROUND:Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. METHODS: In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN09186711. FINDINGS: Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0·97, 95% CI 0·62-1·51; p=0·88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1·38, 95% CI 0·53-3·59, p=0·50), nor did any of the major complications included in the primary endpoint. INTERPRETATION: In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference. FUNDING: The Dutch Digestive Disease Foundation, Fonds NutsOhra, and the Netherlands Organization for Health Research and Development.
RCT Entities:
BACKGROUND:Infected necrotising pancreatitis is a potentially lethal disease and an indication for invasive intervention. The surgical step-up approach is the standard treatment. A promising alternative is the endoscopic step-up approach. We compared both approaches to see whether the endoscopic step-up approach was superior to the surgical step-up approach in terms of clinical and economic outcomes. METHODS: In this multicentre, randomised, superiority trial, we recruited adult patients with infected necrotising pancreatitis and an indication for invasive intervention from 19 hospitals in the Netherlands. Patients were randomly assigned to either the endoscopic or the surgical step-up approach. The endoscopic approach consisted of endoscopic ultrasound-guided transluminal drainage followed, if necessary, by endoscopic necrosectomy. The surgical approach consisted of percutaneous catheter drainage followed, if necessary, by video-assisted retroperitoneal debridement. The primary endpoint was a composite of major complications or death during 6-month follow-up. Analyses were by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN09186711. FINDINGS: Between Sept 20, 2011, and Jan 29, 2015, we screened 418 patients with pancreatic or extrapancreatic necrosis, of which 98 patients were enrolled and randomly assigned to the endoscopic step-up approach (n=51) or the surgical step-up approach (n=47). The primary endpoint occurred in 22 (43%) of 51 patients in the endoscopy group and in 21 (45%) of 47 patients in the surgery group (risk ratio [RR] 0·97, 95% CI 0·62-1·51; p=0·88). Mortality did not differ between groups (nine [18%] patients in the endoscopy group vs six [13%] patients in the surgery group; RR 1·38, 95% CI 0·53-3·59, p=0·50), nor did any of the major complications included in the primary endpoint. INTERPRETATION: In patients with infected necrotising pancreatitis, the endoscopic step-up approach was not superior to the surgical step-up approach in reducing major complications or death. The rate of pancreatic fistulas and length of hospital stay were lower in the endoscopy group. The outcome of this trial will probably result in a shift to the endoscopic step-up approach as treatment preference. FUNDING: The Dutch Digestive Disease Foundation, Fonds NutsOhra, and the Netherlands Organization for Health Research and Development.
Authors: Guru Trikudanathan; Hiba Hashmi; Ahmed Dirweesh; Stuart Amateau; Nabeel Azeem; Shawn Mallery; Martin L Freeman Journal: Endosc Int Open Date: 2020-04-17
Authors: Lu Ke; Wenjian Mao; Jing Zhou; Bo Ye; Gang Li; Jingzhu Zhang; Peng Wang; Zhihui Tong; John Windsor; Weiqin Li Journal: World J Surg Date: 2019-04 Impact factor: 3.352